13 Aug
|
Sun Pharmaceutical Industries
|
India
13 Aug
Sun Pharmaceutical Industries
India
Job Title:
Senior Manager- Microbiology SME
Business Unit:
Global Quality & Compliance
Job Grade
G9
Location:
Tandalja, Vadodara
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a team-oriented spirit, knowing that we ‘Thrive together’ and support each other’s journeys’.
Key Responsibilities:
- Act as Global Microbiology Subject Matter Expert (SME) for sterile pharmaceutical manufacturing, microbiology laboratories, and sterility assurance practices.
- Establish and lead the Global Sterility Assurance Review Board, including governance, charter, review cadence, escalation criteria, minutes, action tracking and effectiveness monitoring.
- Strengthen global review of microbiology and sterility assurance deviations, with emphasis on root cause adequacy, contamination control impact, CAPA robustness, and recurrence prevention.
- Provide independent expert review and guidance for aseptic processing, environmental monitoring, personnel monitoring, contamination events, sterility test failures, media fills, bioburden, endotoxin, and microbiological method-related investigations.
- Partner with site Quality, Microbiology, Manufacturing, Sterility Assurance, Engineering, Validation, and Regulatory teams to drive consistent investigation quality and timely closure of high-risk microbiology events.
- Review and challenge microbiological trending, adverse trends, repeat events, and signals from environmental monitoring, water systems, compressed gases, utilities, cleaning, disinfection, and aseptic operations.
- Support Contamination Control Strategy (CCS) review and continuous impro
📌 Senior Manager- Microbiology SME (India)
🏢 Sun Pharmaceutical Industries
📍 India