Role Summary
Lead the site's Sterility Assurance Program by ensuring robust contamination control, aseptic process compliance, microbiological oversight, and adherence to global regulatory requirements.
Key Responsibilities
- Drive and strengthen the Sterility Assurance Program and Contamination Control Strategy (CCS).
- Conduct periodic Sterility Assurance Management Reviews.
- Oversee classified areas, microbiology laboratories, and utility systems to ensure sterility compliance.
- Manage Sterility Assurance Calendar, including reviews, training, qualifications, and re qualification.
- Ensure compliance of cleanrooms, personnel, equipment, facilities, and utilities impacting product sterility.
- Review and approve validation, qualification, and protocol studies affecting sterility assurance.
- Lead Media Fill Programs (Aseptic Process Simulations) and aseptic process oversight.
- Review and investigate microbial OOS, OOT, and environmental excursions; ensure effective CAPA implementation.
- Oversee Environmental Monitoring (EM) and Personnel Monitoring programs.
- Review microbial trend data and drive proactive risk mitigation actions.
- Assess and approve change controls impacting sterile manufacturing, facilities, utilities, and processes.
- Ensure gowning qualifications, aseptic interventions, and contamination control practices are effectively managed.
- Drive training programs on aseptic behavior, contamination control, and sterility assurance.
- Ensure microbiological testing complies with pharmacopeial and regulatory requirements.
- Maintain Data Integrity compliance across microbiology and sterility assurance activities.
- Support regulatory inspections and audits as Sterility Assurance SME.
Qualification: M. Pharma/ M.Sc. Microbiology or equivalent.
Experience: 14–18 Years.
Industry: Sterile Injectable / USFDA Approved Pharmaceutical Manufacturing
