Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience as Pfizer Animal Health, we deliver quality medicines and vaccines, complemented by diagnostics products and genetics tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.
Post: Quality Assurance- Scientist
Job Description
Position Summary
This position summarizes the various Quality Assurance responsibilities including vendor evaluation & approval for carrying-out development, scale up, VICH activities and supporting the projects from QA perspectives, review and release of batches for various clinical and non-clinical studies, supporting QA review for regulatory CMC filing, establishing quality management systems within R&D and Pilot plant though SOP's, guidelines & self-inspections etc. Position requires complete understanding of NCE's and Generics requirements from QA perspective (API and Formulation )
Role and Responsibilities
- Supporting and Guiding Various departments ( Chemical Research, Formulation Research, Analytical Research, Procurement and Pilot plant) in preparation of Procedures and Policies, in conjunction with Global procedures of Zoetis and meeting the regulatory requirements of USFDA, European regulations, Brazil ( MAPA registration) etc. Should have an understanding and clarity with respect to Qualified Personnel for release of batches in EU.
- Thorough understanding of systems and procedures with respect to Qualification and QA process of manufacturing of API in a plant (Pilot Plant and cGMP manufacturing).
- GMP Clinical batches documentation review and Release for API & Formulations manufactured (NCE and Generics) across the VMRD, Review and Release of clinical batches in line with regulatory requirements.
- Complete understanding of systems and procedures with respect to QA process of manufacturing of Drug Product (development procedures and cGMP manufacturing prior to commercialization)
- Supporting the procurement group Pharmaceutical Sciences (R&D) in Vendor Qualifications process for API, DP and PM the globe, like Vendor Quality Audits and evaluation. Contract Testing Laboratories required for R&D for method validation and stability.
- Implementation of Quality Agreements with Vendors ( Internal and External), Periodic vendor audits to assure GMP Compliance, Change control management, OOS investigations review and approval from Vendors from PS.
- Supporting projects of API and Formulations from QA Perspective. Supporting Training Function in various departments.
- Complete understanding of GMP training and its evaluation.
- Experienced in various regulatory inspections and audits.
- Approval of various GMP documents in absence of Head- Quality Assurance & Documentation.
- In depth knowledge of Global Quality guideline, best practices and lab compliance.
- Good understanding of record keeping and archival.
Preferred Skills
Good communication, drafting, interpersonal and presentation skills. full understanding of good documentation practices, command on Microsoft word, excel, PowerPoint etc
Additional Information:
Experience: 5-10 Year, In Pharmaceutical R&D (API &DP)/Pilot plant
Qualification: M.Pharm, M.Sc
Location: Turbhe - Navi Mumbai
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
Job Reference: 5001234
End Date: 25th May, 2015
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