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 workplace 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 collaborative spirit, knowing
that we ‘Thrive together’ and support each other’s journeys’.

Key Responsibilities:

1. Act as Global Microbiology Subject Matter Expert (SME) for sterile
pharmaceutical manufacturing, microbiology laboratories, and sterility
assurance practices.
2. Establish and lead the Global Sterility Assurance Review Board, including
governance, charter, review cadence, escalation criteria, minutes, action
tracking and effectiveness monitoring.
3.



Strengthen global review of microbiology and sterility assurance
deviations, with emphasis on root cause adequacy, contamination control
impact, CAPA robustness, and recurrence prevention.
4. 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.
5. 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.
6. Review and challenge microbiological trending, adverse trends, repeat
events, and signals from environmental monitoring, water systems,
compressed gases, utilities, cleaning, disinfection, and aseptic
operations.
7. Support Contamination Control Strategy (CCS) review and continuo

📌 Senior Manager- Microbiology SME (Vadodara)
🏢 Sun Pharmaceutical Industries
📍 Vadodara