Title:  Senior Manager- Microbiology SME

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

Travel Estimate

Minimal to moderate travel (as per project, audit, or site requirements)

Job Requirements

Educational Qualification

Master’s Degree in Microbiology.

Advanced specialization/certification in Sterility Assurance, Aseptic Processing, Contamination Control or Pharmaceutical Microbiology will be an added advantage.

Experience

Tenure:  

Minimum 12 years

1. Minimum 8+ years of hands-on experience in pharmaceutical microbiology, sterility assurance, aseptic processing support, or quality microbiology for sterile manufacturing operations.
2. Strong experience in microbiology deviation investigations, sterility assurance events, and CAPA design/effectiveness assessment.
3. Mandatory exposure to sterile pharmaceutical operations, aseptic processing, environmental monitoring, media fills, sterility testing, bioburden/endotoxin testing, water and utility microbiology, and contamination control.
4. Demonstrated ability to lead or participate in global/site-level governance forums, review boards, quality councils, or cross-functional investigation review meetings.
5. Sound knowledge of global regulatory expectations and guidelines applicable to sterile manufacturing and microbiology, including USFDA, EU GMP Annex 1, WHO, MHRA and PIC/S expectations.
6. Proven experience in supporting regulatory audits/inspections and responding to microbiology, sterility assurance, contamination control, and investigation-related observations.
7. Strong technical writing, investigation review, risk assessment, data trending, problem-solving and decision-making skills.
8. Demonstrated ability to influence senior stakeholders, coach site teams, manage cross-functional projects, and communicate effectively across regions.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).