Bharat Serums and Vaccines Limited CQA OFFICER B.Pharma - M.Pharma
Job Description
1. Prepare and execute periodic on-site audit of Contract
Manufacturing Organizations (P to P & Loan License) and Raw Material
Vendors.
2. Periodic visit to all Loan License manufacturing sites
during manufacturing of BSVL products to ensure quality & compliance.
3. Preparation of GMP audit reports and review of the audit
response to comply the regulatory & BSVL requirements.
4. To prepare Quality Responsibility Agreements with Contract
Manufacturer Organizations.
5. To report and investigate critical changes & deviation
w.r.t BSVL products at Contract Manufacturing Organizations.
6. To investigate quality complaint of BSVL products &
review the CAPA plan at Contract Manufacturing Organizations.
7. Review of samples and Batch process documents of Contract
Manufacturing Organizations.
8. To prepare and execute CQA SOP's.
9. To coordinate training programs for various department.
10. To plan and perform the internal audit for various
department.
11. To prepare documents related to Technology Transfer of
Loan Licence products and coordinate technology transfer procedure.
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