Work at Pfizer as Manager - Quality Assurance

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post: Manager - Quality Assurance

Job Description:
Position Summary:
This position summarizes the various Quality Assurance responsibilities including vendor evaluation & approval for carrying-out VMPS activities, supporting the projects from QA perspectives, review and release of batches for various clinical and non-clinical studies, supporting regulatory CMC filing, establishing quality systems within VMPS though SOP's, guidelines & self-inspections etc.

Essential Duties and Responsibilities:
Supporting and Guiding Various departments (formulation Research,vendor Management) in preparation of Procedures and Policies, in conjunction with Global procedures of Pfizer and meeting the regulatory requirements of Indian FDA,USFDA,European regulations etc.
GMP Clinical batches documentation review and Release forFormulations manufactured across the VMRD ( India Centric)
Review and Release of clinical batches.
Supporting the Business Development at VMPS in Vendor Qualifications process for Drug Product, like Vendor Quality Audits and evaluation with respect to compliance to GMP and Pfizer Policies.
Supporting Business Development in qualification of Contract Testing Laboratories required for VMPS to carry out method development, method validation, stability testing for various projects.
Implementation of Quality Agreements with Vendors.
Periodic vendor audits to ensure continuous compliance with GMP.
Change control management, deviations management, OOS investigations review and approval from Vendors and from VMPS, Thane.
Supporting various development projects Formulations from QA perspective.
Supporting Training Function in various departments.
Auditing the Vendor site for GMP compliance.
Establishing Quality Systems for Bio Pharmaceuticals along with Head-QA ( Business Driven Products)

Candidate Profile:
8-10 years total experience, out of which at least 5 years must be in a Managerial capacity,
Experience in Quality Assurance of an API/Drug Product.
Qualifications - Msc / B.Pharm / M. Pharma

Additional Information:
Experience: 8-10 Years
Location: Thane
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
Job ID: 967119