Thursday, January 27, 2011

Resume' Writing

Clinical Research Associate - Bio Equivalance require in Macleods | 2 openings

Candidates having 1 - 3 yrs of experience in Bio clinical dept. With qualification of M.pharm(pharmacology) or M.Sc (Clinical research)

Clinical Research Associate - Bio Equivalance require in Macleods | 2 openings

Macleods has its presence in over 30 countries with more than 300 registrations.
The export range of Macleods are manufactured in a unit that has QSM approval from WHO-Geneva, and certifications from various International Regulatory Authorities like - USFDA, MCC, UKMHRA, MOH – Belarus, INVIMA – Colombia, National Drugs Authority - Uganda, Food and Drugs Board - Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya, Pharmacy Board Tanzania etc.

Post: Clinical Research Associate - Bio Equivalance

Job Description:
- Study co- ordination
- Plasma separation
- Custodian role
- ICF (Inform consent form) presentation

Candidate Profile:
- Candidates having 1 - 3 yrs of experience in Bio clinical dept
- With qualification of M.pharm(pharmacology) or M.Sc (Clinical research)

Other Information:
Experience: 1-2 years
Education: M.Pharm, M.Sc
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR

Candidate may mail their resume at, rndhrd@macleodspharma.com

Wednesday, January 26, 2011

Sr Research Associate - (Assay Development and Compound Screening) require in Syngene International

Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.

Post: Sr Research Associate - (Assay Development and Compound Screening)

Job Description:
• Responsible for developing and performing cell-based functional assays against disease-specific targets
• Screening of compounds generated by Medicinal chemistry groups in dose-response assays
• Data analysis & IC50 determination
• Data upload in specific templates & sharing with client via shared site

Candidate profile:
• 3-4 years of relevant work experience in assay development and compound screening in a CRO or industrial setting
• Extensive experience with mammalian cell culture and a wide range of cellular assay techniques. Experience with biochemical and molecular techniques a plus
• Thorough knowledge in assay platforms based on fluorescence & scintillation proximity, use of data analysis software and in use of high-end plate readers
• Should be well-versed in plate-based compound dilutions and plate map formats
• Prior experience in use of 384-well formats and automation for screening will be of great advantage
• MSc (Biological Sciences)/MVSc/M. Pharm from a reputed University

Additional Information:
Experience: 3-4 years
Location: Bengaluru/Bangalore
Education: M.Pharm, MVSc, M.Sc
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: Healthcare, Medical, R&D

Multiple Vacancies in Comed Pharma for Marketing, Production, QA, QC

M.Pharm, B.Pharm, B.Sc, M.Sc; capability for exploring new avenues, leading a well qualified, energetic team to achieve planned targets with analytical professional approach.

Sr Research Associate - (Assay Development and Compound Screening) require in Syngene International

Multiple Vacancies in Comed Pharma for Marketing, Production, QA, QC

Comed was in 1986, when a team of experienced and energetic Pharma professional decided to go big and to do something different and better than routine. A seed was sown: a beginning was made. These young, dynamic and experienced future leaders chose Baroda (Now called Vadodara), the Educational and Pharma capital of Gujarat (Western India) as their base, a choice which itself proved to be big contributing factor for growth.
The group today manufactures 7 million Empty Hard Gelatin Capsules per day on latest fully automatic and computerized capsule lines and is a regular supplier to best of the companies.
The group has its overseas offices in Dubai, Nairobi (Kenya), Lusaka (Zambia) and Colombo (Sri Lanka) and is fast registering more and more products into various countries.

Post: VICE PRESIDENT ( MARKETING )
M.Sc/B.Sc/B.Pharm preferably MBA (Mktg) with atleast 20 yrs exp. of handling Marketing activities in a reputed pharma company having all India presence and must have worked at a similar position for min 05 years. Capability for exploring new avenues, leading a well qualified, energetic team to achieve planned targets with analytical professional approach.

Post: GENERAL MANAGER(QC/QA)
M.Sc./M. Pharm with atleast 20 yrs exp. of which min. 5 yrs as incharge of QC/QA deptt. in Pharmaceutical industry. Well acquainted with instruments like HPLC/GC/IR/UV & with international statutory requirements like GLPs. CGMPs etc.

Post: SENIOR PRODUCT MANAGER/PRODUCT MANAGER
B. Pharm/B.Sc , preferably MBA, with 8-12 yrs experience of product management activities in a reputed pharma company.

Post: PRODUCT EXECUTIVE
B.Pharm/B.Sc, preferably MBA, with min. 03 yrs exp of product management activities in a reputed pharma company.

Post: BUSINESS DEVELOPMENT MANAGER (EXPORT)
Graduate/Post Graduate with specialization in export marketing, min. 6 yrs exp. and capable of managing independently export functions of a pharma company. Should be thoroughly conversant with African, Far and Middle East markets..

Post: EXPORT EXECUTIVE
B. Pharm, with min. 3 yrs exp in export division of a reputed pharma company with good knowledge of pharmacological details and preparation of export dossiers

Post: CHEMISTS (QC/QA):
M.Pharm/B.Pharm with more than 02 yrs exp with reputed pharma laboratory. Knowledge of modern analytical instruments essential.

Interested candidates may send their detailed resume within 07 days {on or before 2^nd feb, 2011} to,
GENERAL MANAGER- HR & ADMN
COMED CHEMICALS LTD
2nd FLOOR, ORIENT BUSINESS CENTRE,
SAYAJIGUNJ,
BARODA.(GUJARAT)
Email: hr@comedchemicals.com

GRE Stuff

Tuesday, January 25, 2011

Valid Analytical Methods & procedure

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This handbook attempts to select or define robust procedures that ensure the best use of resources and enable laboratories to generate consistent, reliable data. Written in concise, easy-to-read language and illustrated with worked examples, it is a guide to current best practice and establishes a control framework for the development and validation of laboratory-based analytical methods. Topics include samples and sampling, method selection, equipment calibration and qualification, method development and validation, evaluation of data and statistical approaches for method performance and comparison.

Development and Validation of Analytical Methods

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The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations.

The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.

Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples.

Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.

This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation

Pharmaceutical Process Validation: An International Third Edition

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The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

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This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential core task when establishing and maintaining compliance with global regulatory authorities, such as the FDA and the MHRA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.

Validation of Toxicogenomic Technologies

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Toxicogenomics has been described as a discipline combining ex-pertise in toxicology, genetics, molecular biology, and environmental health to elucidate the response of living organisms to stressful environ-ments. It includes the study of how genomes respond to toxicant expo-sures and how genotype affects responses to toxicant exposures. As the technologies for monitoring these responses rapidly develop, it is critical that scientists and regulators are confident that the technologies are reliable and reproducible and that the data analyses have been validated. To discuss these issues in a public forum, the Committee on the Validation of Toxicogenomic Technologies designed a workshop to consider the current practice and advances in the validation of toxicogenomic tech-nologies. The workshop focused on the technical aspects of validation, recognizing it as a prerequisite for considering other important issues, such as biological validation (e.g., validating the use of microarray “sig-natures” to describe a toxic effect).

Development and Validation of HPLC Methods for Analytical and Preparative Purposes

Liquid chromatography (LC) is a separation method of great importance to the chemical, pharmaceutical and biotechnological industry. The principle is that a sample of a solution of the substances is injected into a column of an porous material (stationary phase) and a liquid (mobile phase) is pumped through the column. The separation of substances is based on differences in rates of migration through the column arising from different partition of the substances between the stationary and the mobile phase. Depending on the partition behavior of the different types of substances, these will elute at different times from the column outlet.

Validation of Pharmaceutical Processes, 3rd Edition

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title · provides an in-depth discussion of recent advances in sterilization · identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions · explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results · blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

The Aqueous Cleaning Handbook: A Guide to Critical-Cleaning Procedures, Techniques and Validation

This book distills and presents practical information covering the history of aqueous cleaners-- what they are, how they work, and how to make best use of them in cleaning products and components in electronics, metalworking, precision manufacturing, food-and-beverage, pharmaceutical, and chemical processing; and many other industrial applications.

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries,

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

In the FDA regulated environment, it is not acceptable for programmers or their managers to deviate from standardized methodologies. Given the type of software commonly found in FDA regulated operations, the criticality and complexity of computer systems, the evolving regulatory climate, and the current industry best practices, validating computer systems can be problematic. Covering regulatory requirements stipulated by FDA and GAMP guidelines, 21 CFR 11: Complete Guide toInternational Computer Validation Compliance for the Pharmaceutical Industry delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. Whether you need to validate computer systems for pharmaceutical cosmetic, food, or medical devise applications, this book is indispensable. Discussing the regulatory requirements that are the foundation for any project, the book introduces a model that can be used to determine the Part 11 requirements for consideration during implementation. The book establishes a top-down approach to the integration of computer systems validation strategies in support of a computer systems validation project. It focuses on practical issues in computer systems implementation and operational life project management, including relevant activities to comply with Part 11, validation planning, and scheduling. The book reviews documentation in relation to CSV and procedural controls in regulated operations. The book shows how to enable compliance with computer systems validation requirements while highlighting and integrating Part 11 requirements into the entire computer validation program. The author places regulatory compliance within the context of quality assurance and emphasizes the importance of integrating validation into the system lifecycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance

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Process Validation in Manufacturing Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.

Validation in Chemical Measurement

The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.

Target Validation in Drug Discovery

This work presents a comprehensive contemporary framework for approaching target validation in drug discovery. It begins with a detailed description of new enabling technologies, including aptamers, RNA interference, functional genomics, and proteomics. The next section looks at biologic drug development with in-depth discussion of lessonslearned from such well-known cases as Erbitux, Herceptin, and Avastin. Additional targets known as "second generation" drugs, which can be identified when disease pathways are validated by biologics, present new possible small molecule therapeutics and serve as the focus of the final section of the book

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Validated Cleaning Technologies for Pharmaceutical Manufacturing

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Validating Medical Packaging

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include paper- and peopleless plants, GxP compliance, integrating manufacturing systems, electronic signatures, validating asset management systems, enterprise/manufacturing planning systems, lab information management systems, and Local & Wide Area Networks, compliance for IT Infrastructure, IT system maintenance and support, and auditing suppliers, software Integrators, and hardware manufacturers.

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Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products

Hardbound. In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.

Features of this book:

• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry

• Illustrates the different approaches available to attain robustness

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Name Reactions of Functional Group Transformations (Comprehensive Name Reactions)

Review

"Unlike many previous books on name reactions, which present many reactions but treat them superficially, this book provides an excellent selection of useful name reactions, which have been given in depth, well-illustrated, instructional, and well-referenced accounts." (Journal of Medicinal Chemistry, February 2008) "Helps you explore how you think, communicate and react, allowing you to change your behaviours and become a more expert professional practitioner." (Journal of Perioperative Practice, April 2008)

"Reading this book has been enjoyable experience. Again and again, one comes across surprising reaction possibilities of well-known reagents, or some lesser known variants of common transformations." (Angewandte Chemie)

"This book provides an excellent selection of useful name reactions, which have been given in depth, well-illustrated, instructional, and well-referenced accounts." (Journal of Medicinal Chemistry, January 11, 2008)

Description

This practical, well-organized reference delves deeply into functional group transformations, to provide all the detailed information that researchers need.

Topics are organized into the following sections: oxidation, reduction, asymmetric synthesis, and functional group manipulations
Each section includes a description of the functional group transformation, the historical perspective, mechanisms, variations and improvements on the reaction, synthetic utilities and applications for the reaction, experimental details, and references to the primary literature
Contributors are well-known and respected for their work on the specific name reactions.

Monday, January 24, 2011

Culture of Animal Cells: A Manual of Basic Technique, 5th Edition

Culture of Animal Cells: A Manual of Basic Technique, 5th Edition

Publisher: Wiley-Liss | 2005 | PDF | 696 pages | ISBN: 0471453293 |

Size : 8.1Mb

Description :

The most complete resource on the techniques, equipment,principles, and practices of animal cell culture Since publication of the previous edition of this benchmark text, numerous groundbreaking advances have occurred in stem cell research, cloning, tissue engineering, and in vitro toxicity testing. These and other developments have been incorporated into this fully revised and expanded Fifth Edition of Culture of Animal Cells. In addition, to answer the needs of the exponential increase in newcomers to cell culture, particularly in the biopharmaceutical industry, a completely new chapter on training in cell culture technology has been introduced. The most complete resource on the techniques, equipment, principles, and practices of animal cell culture, this text offers a complete background related to growth of animal cells in culture. Beginning with laboratory design, safety, validation and bioethics, then continuing with preparation of media, primary culture and cell lines, through to characterization and authentication, contamination, specialized techniques, and troubleshooting, the coverage includes: * An all-new section of training exercises, separated into basic, intermediate, and advanced procedures, cross-referenced to the relevant protocols * New coverage of stem cells, bioethics, validation, cloning, cell signaling, in vitro toxicity testing, and tissue engineering * An expanded full-color atlas section, with images of primary culture, cell lines, subculture, differentiation, cancer cells and transformation, three-dimensional culture, contamination, and specialized equipment * Enhanced treatment of troubleshooting, with full cross-referencing to the relevant protocols and sections of text * Fully updated references * The clearest, most consistent presentation of step-by-step protocols available * Numerous diagrams, photographs, tables, and charts * Detailed and up-to-date information on reagent preparation and sourcing of materials and equipment, including a fully updated list of suppliers and other resources with Web sites

Indispensable for clinical and biopharmaceutical researchers and scientists, students, trainees, and technicians, this landmark text presents the most accessible and comprehensive introduction available to the culture and experimental manipulation of animal cells.

Alternate Link

http://www.fileserve.com/file/wDtBux8/0471453293.rar

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