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
- 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)
- 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
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
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.
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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
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.
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
