Senior General Manager

Senior General Manager - Corporate QA (Sterile Assurance)

1. Harmonization of procedures and practices:

a. Draft / review / update Policies, Procedures related to Microbiology and Sterile Assurance.

b. Harmonize the Procedures related to Microbiology and Sterile Assurance across all units

2. Improving breadth and depth of Knowledge:

a. Identify and lead a network of Microbiology / Sterile Assurance Subject Matter Experts.

b. Act as a CQA Trainer for Microbiology and Sterile Assurance related Training programs.

3. Investigations and CAPA:

a. Act as CAPA coordinator for the CAPA related to Microbiology and Sterile Assurance.

b. Part of Investigations Team for Microbiology and Sterile related Investigations.

c. Act as Cross Functional Reviewer (CQA) for Microbiology and Sterile Assurance related changes, Non conformances, OOS etc, wherever applicable.

4. Act as Internal Auditor for Microbiology and Sterile Assurance area, wherever required.

5. Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their sterility assurance systems are properly prepared for external and internal compliance inspections.

6. Escalate Microbiology and Sterile Assurance related issues to Senior Management.

Years of Experience 22-25 years

Education Qualification for the position M.Pharm, M.Sc (Microbiology)

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