Microbiologist

GNT Page Private Limited; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Pharmaceuticals MNC Company (OSD Formulation) in Bavla/Ahmedabad, Gujarat, India seeks an experienced Approved Microbiologist to lead the microbiology laboratory setup and qualification. You will design EM programs, oversee IQ/OQ/PQ, and ensure compliance with EU WHO GMP standards while building and mentoring a skilled team.

Role demands strong regulatory inspection experience, development of SOPs and quality systems, and effective containment of contamination control strategies across

Qualifications

• Must hold M.Sc. Microbiology or equivalent with lab leadership experience.
• Experience in setting up microbiology labs and qualification work.
• Familiarity with regulatory inspections and GMP requirements.

Responsibilities

• Function as Approved Microbiologist for the manufacturing site.
• Lead establishment and qualification of the Microbiology Laboratory including layout, equipment and workflow.
• Develop microbiology laboratory systems in GMP/regulatory compliance.
• Prepare and implement SOPs, specs, qualification protocols and quality systems.
• Lead IQ, OQ and PQ activities for microbiology lab equipment.
• Establish Environmental Monitoring programs for classified areas.
• Design microbial monitoring strategies for cleanrooms, personnel and utilities.
• Lead microbiological method validation, verification and transfer.
• Establish Water Monitoring Program including PW and utilities.
• Conduct microbial investigations and address OOS/OOT events.
• Ensure Data Integrity, GDP and laboratory quality systems compliance.
• Support regulatory inspections and customer audits of the microbiology facility.
• Represent microbiology during inspections and audits.
• Build, train and mentor the microbiology team.

Skills

Approved Microbiologist

GMP Compliance

Environmental Monitoring

IQ/OQ/PQ

Method Validation

Team Leadership

Education

M.Sc. Microbiology

Laboratory Setup & Qualification

Contamination Control

Regulatory Inspection Management

Team Leadership & Development

Job description

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.
• Microbiology Laboratory Setup & Qualification.
• Contamination Control Strategy.
• Regulatory Inspection Management.
• Team Leadership and Development