QC Executive

About the role

The QC Executive is responsible for independently managing and operating the microbiology laboratory in compliance with ISO 13485, Good Laboratory Practice (GLP), and applicable quality and regulatory requirements. The role performs microbiological testing and environmental monitoring, manages laboratory documentation and equipment, oversees pest control monitoring, conducts data trending and investigations, manages related corrective and preventive actions (CAPA), provides Good Manufacturing Practice (GMP) training, and supports audits.

Key responsibilities

• Independently manage and perform routine microbiology laboratory activities, including media preparation, growth promotion testing as applicable, laboratory housekeeping, inventory control, and waste decontamination.
• Perform bioburden testing for finished products and/or incoming materials in accordance with approved procedures.
• Perform microbiological method validation, verification, or suitability studies as required.
• Perform microorganism identification testing and support investigations of microbiological contamination.
• Coordinate external endotoxin testing for finished products and review the test results and reports.
• Perform environmental monitoring for the ITLAP cleanroom, controlled areas, and extrusion water system, including microbial, particulate, temperature, relative humidity, and differential pressure monitoring, as applicable.
• Review and trend microbiological testing and environmental monitoring data and initiate investigations when established limits or requirements are not met.
• Manage and monitor the pest control programme and review service reports and identified issues.
• Operate, monitor, and maintain microbiology laboratory equipment and coordinate calibration, maintenance, or servicing as required.
• Maintain complete and accurate laboratory worksheets, test records, environmental monitoring records, equipment records, and related quality records.

About you

• Knowledge of ISO 13485, Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP)
• Experience with microbiological testing and environmental monitoring
• Ability to develop, review, and update Standard Operating Procedures (SOPs), Work Instructions (WIs), and Safe Work Procedures (SWPs)
• Experience investigating microbiological test failures, environmental monitoring excursions, and contamination events
• Ability to initiate and manage corrective and preventive actions (CAPA)
• Technical expertise in microbiology, environmental monitoring, and contamination control
• Experience providing support during internal, customer, certification, and regulatory audits