MUST BE FROM PHARMACEUTICAL
Key Responsibilities
- Sterility Assurance & Contamination Control: Maintain and execute the site's Contamination Control Strategy (CCS), overseeing media fills (aseptic process simulations), sterility testing, bioburden, and bacterial endotoxin testing.
- Environmental Monitoring (EM): Supervise routine EM of cleanrooms, compressed gases, and process utilities (WFI, purified water) to detect viable and non-viable particulates.
- Deviation & CAPA Management: Lead Out-of-Specification (OOS) and Out-of-Limits investigations. Identify root causes for microbiological excursions and design effective Corrective and Preventive Actions (CAPA).
- Audit Readiness & Compliance: Act as the subject matter expert (SME) during regulatory inspections (FDA, MHRA, CDSCO) and customer audits.
- Lab Operations & Team Management: Manage day-to-day QC laboratory operations, mentor microbiologists, review data, and manage the departmental budget.
Qualifications & Requirements
- Education: M.Sc. in Microbiology, Biotechnology, or B.Pharm/M.Pharm.
- Experience: 8 to 15+ years in the pharmaceutical industry, with at least 3-5 years in a managerial role specifically within a sterile/injectable manufacturing facility.
- Technical Expertise: Strong knowledge of aseptic techniques, aseptic behavior, cleanroom design, rapid microbial methods (RMM), and microbial identification.
- Regulatory Knowledge: Deep understanding of cGMP guidelines, Good Documentation Practices (ALCOA+), and EU GMP Annex 1 requirements.
Pay: ₹40,000.00 - ₹70,000.00 per month
Work Location: In person
