Compounding Quality Assurance Specialist
3 weeks ago
Key Responsibilities:
The role of the Compounding QA In-process Controller is to provide Quality Assurance support throughout the compounding center. This includes ensuring that the quality of products produced consistently meets GMP and regulatory requirements.
Quality Assurance Support:
- Perform daily walkabouts in the compounding center to identify and report any quality issues.
- Ensure validations are carried out as per SOP and according to the yearly schedule.
- Perform media fills as per SOP and according to the yearly schedule.
Daily QA Manufacturing Activities:
- Record drop test information daily and ensure the integrity of all isolators is properly maintained.
- Observe leak tests when performed.
- Approve bio-decontamination cycles to start by verifying all the pre-bio-decontamination checks.
Documentation and GMP Adherence:
- Ensure accurate documentation of all QA checks in the compounding center.
- Ensure appropriate filing of all QA log sheets.
- Ensure good documentation and record keeping practices.
Staff Supervision and Training:
- Be available for duty after hours and on required Production weekends to complete related QA-IPQC duties.
- Continuous supervision of production staff on quality matters.
Requirements:
- Minimum requirement: Matric Pharmacist assistant course (Basic or Post-Basic).
- Previous employment within a Production or QA pharmaceutical manufacturing environment with a proven track record.
- Thorough knowledge of cGMP principles.
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