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 collaborative 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 improvement aligned with current global regulatory expectations and site risk profile.
- Provide technical support during regulatory inspections, health authority commitments, customer audits, and global quality reviews related to microbiology, sterility assurance, and aseptic operations.
- Lead cross-site knowledge sharing, training, and capability building for microbiology investigations, sterility assurance, contamination control and data integrity expectations.
- Drive standardization, simplification, and lifecycle improvement of microbiology investigation review processes without compromising patient safety, product quality or compliance.
- Ensure strong adherence to CGMP, data integrity principles (ALCOA++), Good Documentation Practices, and applicable global regulatory requirements.
