Assistant Manager – Microbiology (OSD)Location: Bavla / Ahmedabad, Gujarat, India
Company: Pharmaceuticals MNC Company (OSD Formulation)Department: MicrobiologyKey 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 Developmentshare your resume at info@gntpage.com or Whatsapp at 8929700006