Senior Manager Microbiology (Sterile facility)

Acme Formulation; Solan; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Acme Formulation in Solan, India seeks a senior microbiology professional to lead the microbiology lab ensuring cGMP, GLP, and data integrity compliance. You will manage daily activities, review records, and coordinate with QA, production, and other departments.

Responsibilities include leading investigations (OOS/OOT), CAPA execution, training, and maintaining equipment and resources, while driving continuous improvement and audits readiness with USFDA and global agencies.

Responsibilities

• Ensure compliance with gowning/de-gowning procedures as per SOPs.
• Adhere to cGMP, GLP, and Data Integrity requirements.
• Plan, allocate, and supervise daily activities of the Microbiology team.
• Review microbiological test records, worksheets, and reports.
• Ensure timely execution of routine microbiological testing and environmental monitoring.
• Execute and review qualification, validation, and method validation activities.
• Prepare and review SOPs, protocols, reports, and microbiology documentation.
• Coordinate with QA, Production, Engineering, and other departments for smooth lab operations.
• Lead investigations for OOS, OOT, deviations, contamination events, and CAPA implementation.
• Conduct training and competency assessment of microbiology personnel.
• Ensure availability of media, reagents, consumables, and laboratory resources.
• Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.
• Maintain laboratory housekeeping, safety, and regulatory compliance.
• Support audits (USFDA and global agencies) and represent the department.
• Drive continuous improvement and ensure overall compliance of microbiology lab operations.

Job description

Key Responsibilities

1. Ensure compliance with gowning/de-gowning procedures as per SOPs.
2. Ensure adherence to cGMP, GLP, and Data Integrity requirements.
3. Plan, allocate, and supervise daily activities of the Microbiology team.
4. Review microbiological test records, worksheets, and reports.
5. Ensure timely execution of routine microbiological testing and environmental monitoring.
6. Execute and review qualification, validation, and method validation activities.
7. Prepare and review SOPs, protocols, reports, and microbiology documentation.
8. Coordinate with QA, Production, Engineering, and other departments for smooth laboratory operations.
9. Lead investigations for OOS, OOT, deviations, contamination events, and ensure effective CAPA implementation.
10. Conduct training and competency assessment of microbiology personnel.
11. Ensure availability of media, reagents, consumables, and laboratory resources.
12. Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.
13. Maintain laboratory housekeeping, safety, and regulatory compliance.
14. Support and represent the department during internal, customer, and regulatory audits (USFDA and other global agencies).
15. Drive continuous improvement and ensure overall compliance of microbiology laboratory operations.

Preferred candidate profile