Microbiologist

RK HR Management; Bavla; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

RK HR Management seeks an Approved Microbiologist to lead the microbiology laboratory at our manufacturing site in Gujarat. You will oversee lab setup, monitoring programs, SOPs, and QA systems while coordinating regulatory inspections and audits.

You will build and mentor the team, design EM strategies for cleanrooms and utilities, and ensure data integrity and contamination control across the facility.

Qualifications

• Experience in leading microbiology labs in GMP environments.
• Strong understanding of environmental monitoring programs and contamination control.
• Proven ability to implement quality systems and regulatory requirements in a manufacturing setting.

Responsibilities

• 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 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.

Skills

Microbiology

GMP Compliance

Environmental Monitoring

Regulatory Knowledge

Team Leadership

Laboratory Quality Systems

Job description

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.