RK HR Management Private Limited
Website:
rkhrm.com
Job details:
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.
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