QA Assistant (Sampling and Labelling Coordinator)
Coordination and execution of sampling activities for incoming materials including API, Excipients, Packing Materials and Finished Product. Documentation review and audits to ensure sampling and labelling is completed in compliance with regulatory requirements, company policy and procedures.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Coordination and scheduling of sampling activities relating to materials (including but not limited to API, Excipients, Packing Materials and Finished Product) as per SOP, applicable regulations and cGMP.
• Execution of sampling activities and related documentation for materials as per relevant SOP and submit samples for testing in house or arrange shipment to external laboratory
• Co-ordinate with Warehouse, Operations and QC as required for schedule of incoming material, access to sampling equipment (e.g. Isolator) and QC for Testing Schedule
• Completion and review of documentation such as Material Receipts, Sampling paperwork, Labelling, Testing Requests for accuracy, completeness, and compliance to GMP and procedural requirements
• Prepare Standard Operating Procedures, investigations, reports and forms as required
• Lead any investigation related to sampling including co-ordination of investigation team, identification of root cause, report writing and CAPA monitoring.
• Planning and Scheduling e.g. Sampling, Labelling, Cleaning etc.
• Support to QA Operations / IPQA as required
• Participate in and provide support for regulatory, customer and/ or corporate audits
• Ensure that relevant procedures and systems are continually evaluated and updated to reflect regulatory changes, thereby maintaining compliance with regulatory requirements.
Education & Experience:
Minimum Leaving Certificate
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