Assistant Manager - Microbiology

Position Summary

We are seeking a highly skilled and experienced Assistant Manager – QC Microbiology to lead and manage the microbiology function within the Quality Control department. The role involves ensuring effective operation of the microbiology laboratory, compliance with applicable regulatory requirements, and maintaining robust Quality Management Systems (QMS) and Good Laboratory Practices (GLP).

This position is specific to the excipient industry; therefore, sterility testing and sterile product requirements are not applicable. Microbiological activities are focused on non-sterile environments, including purified water systems.

Responsibilities will include:

Microbiology Laboratory Management

• Oversee all microbiological testing activities for raw materials, finished products, and in-process samples.
• Manage environmental monitoring programs where applicable (non-sterile facilities).
• Ensure timely analysis and reporting of results in compliance with specifications.
• Supervise purified water testing and ensure compliance with pharmacopoeial standards.
• Maintain laboratory readiness, including equipment qualification, calibration, and maintenance.

Quality Management System (QMS)

• Handle and oversee QMS activities including:
• Deviations
• Change controls
• CAPA (Corrective and Preventive Actions)
• OOS (Out of Specification) and OOT (Out of Trend) investigations
• Ensure effective implementation and closure of QMS events within defined timelines.
• Support internal audits and regulatory inspections.

GLP Compliance

• Ensure strict adherence to Good Laboratory Practices (GLP).
• Maintain proper documentation practices and data integrity (ALCOA+ principles).
• Review and approve microbiological records, reports, and logbooks.

Compliance & Regulatory

• Ensure QC microbiology operations comply with applicable regulatory guidelines (e.g., pharmacopeias, GMP standards).
• Prepare and review SOPs, protocols, and reports related to microbiology.
• Participate in audits and ensure audit readiness at all times.

Team Leadership

• Lead, train, and mentor microbiology team members.
• Ensure skill development and competency of laboratory personnel.
• Allocate work and monitor team performance.

Required Experience & Knowledge

Education: M.Sc. in Microbiology or related life sciences field

Experience: 5–8 years of experience in QC Microbiology, preferably in pharmaceutical or excipient industry.

Prior experience in handling QMS and GLP systems is mandatory

• Strong knowledge of microbiological testing techniques (non-sterile products)
• Experience with purified water analysis
• In-depth understanding of GMP, GLP, and data integrity requirements
• Strong investigation and problem-solving skills
• Good documentation and communication skills
• Leadership and team management abilities

Supervisory Responsibilities

Yes

Additional Note

• This role does not involve sterility testing or sterile product handling.
• Focus is on excipient microbiological quality and purified water systems.

Reporting To: QC Head / Quality Head