Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s area of activity includes six major therapeutic/product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics.The company markets these products in over 125 countries. Its marketing partners include AstraZeneca and Pfizer.
Name of the post- Senior General Manager- Corporate QA (Sterile Assurance)
Years of Experience- 22-25 years
Education Qualification- M.Pharm, M.Sc (Microbiology)
1.Harmonization of procedures and practices:
- Draft / review / update Policies, Procedures related to Microbiology and Sterile Assurance.
- Harmonize the Procedures related to Microbiology and Sterile Assurance across all units
2. Improving breadth and depth of Knowledge:
- Identify and lead a network of Microbiology / Sterile Assurance Subject Matter Experts.
- Act as a CQA Trainer for Microbiology and Sterile Assurance related Training programs.
3. Investigations and CAPA:
- Act as CAPA coordinator for the CAPA related to Microbiology and Sterile Assurance.
- Part of Investigations Team for Microbiology and Sterile related Investigations.
- 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.
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