Microbiologist

Assistant Manager – Microbiology (OSD)

Location: Bavla / Ahmedabad, Gujarat, India

Company: Pharmaceuticals MNC Company (OSD Formulation)

Department: Microbiology

Key Responsibilities

· Function as Approved Microbiologist for the manufacturing site.

· Lead establishment and qualification of the Microbiology Laboratory including layout review, equipment selection, workflow design and contamination control strategy.

· Develop microbiology laboratory systems in accordance with GMP and regulatory requirements.

· Prepare and implement laboratory SOPs, specifications, qualification protocols and quality systems.

· Lead IQ, OQ and PQ activities for microbiology laboratory equipment.

· Establish Environmental Monitoring (EM) programs for classified manufacturing areas.

· Design microbial monitoring strategies for cleanrooms, personnel and utilities.

· Develop and qualify media preparation support systems.

· Lead microbiological method validation, verification and method transfer activities.

· Establish Water Monitoring Program including PW, potable water and associated utilities.

· Conduct microbial investigations including environmental excursions, OOS, OOT and contamination events.

· Ensure compliance with Data Integrity, GDP and laboratory quality systems.

· Support regulatory inspections, customer audits and qualification of the microbiology facility.

· Thorough understanding of EU GMP, WHO GMP, PIC/S guidance and global contamination control requirements.

· Ability to represent microbiology function during regulatory inspections and customer audits.

· Experience handling inquiries related to Environmental Monitoring, Water Systems, Sterility Assurance and Contamination Control Strategy.

· Build, train and mentor the microbiology team.

Educational Qualification

· M.Sc. Microbiology or equivalent.

Key Competencies

· Microbiology Laboratory Setup & Qualification.

· Contamination Control Strategy.

· Method Validation & Method Transfer.

· Regulatory Inspection Management.

· Team Leadership and Development

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