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.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production , Manufacturing , Maintenance
Role Category:Senior Management
Role:Head/VP/GM-Quality Assurance/Quality Control
Sterility OOS Auditing Capa Senior Management General Management Internal Audit
Desired Candidate Profile:
UG: Any Graduate – Any Specialization
PG:M.Pharma – Pharmacy, M.Sc – Microbiology
Doctorate:Doctorate Not Required
Years of Experience 22-25 years
Education Qualification for the position M.Pharm, M.Sc (Microbiology)
Aurobindo Pharma Ltd
Manufacture of Glass and Glassware products. A Group of Aurobindo Pharma Ltd with 200+ employees