Manager, Quality

Responsibilities

• Create, review and approve SOPs/WIs/Standard forms for Life Science & Healthcare Operations
• Document review to ensure that there is no SOP/WIs that are overdue
• Record, report and register non-conformance and customer complaints under CAPA and drive the closure of the cases
• Play an active role in change control documentation
• Compile data on QMS Processes and report on monthly basis
• Maintain site certifications and support Internal, customer and regulatory audits
• Review the daily temperature records for ambient storage, chillers and freezers, play an active role if there are any temperature excursions
• Ensure the temperature and humidity mapping activities are carried out as per the current standards and product requirement
• Review mapping protocol and report any deviation
• Review all equipment lists and ensure calibration is done as per schedule
• Maintain records in eQMS system
• Perform training to the relevant personnel on quality processes
• Ensure that the products are stored as per the products storage requirements and have identification and status
• Ensure the quarantine products are stored under lock and key and disposition of quarantine products is done only after customer approval.
• Review the daily cleaning records, monthly pest control records and perform quarterly maintenance checks on the warehouse
• Perform self-assessment for site
• Perform risk assessment for all operational processes Inbound, Outbound, Storage Control
• Perform audit on operational processes and ensure compliance
• Review the daily cleaning records
• Review the monthly pest control records
• Perform Quarterly Maintenance Checks of the warehouse e.g. aircon.
• Ensure QMS compliance
• Any ad-hoc tasks as assigned by supervisor

Requirements

• Diploma in any discipline
• 8 to 10 years of experience in similar capacity in Life Science or Pharmaceutical operations
• Possess Quality Management System (QMS) certification
• Proficient in Microsoft Excel
• Good communication and writing skills