Accountable for Quality oversight for review and release of finished goods, raw materials, and packaging components. Maintains routine programs and processes to ensure high quality product and compliance with current cGMPs.
Requirements
- Support Manufacturing batch record review activities.
- Prepare and issue Production Batch Records.
- Perform review and release activities related to finished goods, raw materials, and packaging components.
- Assist in the development and implementation of QA systems and SOPs.
- Initiate and assist in Quality Investigations of cGMP products as required.
- Generate Incident Reports, Change Controls and CAPA reports as required.
- Perform initiation, maintenance and closure activities of Quality Assurance Operations systems such as discrepancies, CAPAs, and Change Control to support QA operations and ensure compliance with SOPs.
- Identify, investigate, and prepare reports on quality issues.
- Interpret generated data and communicate results to Quality Management.
- Maintain effective communication and partnership with Operations department and Materials Management.
- Maintain relevant training.