Complaints Quality Assurance Specialist
4 weeks ago
Job Summary
We are seeking a highly skilled Quality Assurance Officer to join our team at CHR Life Sciences. The successful candidate will be responsible for maintaining and continuously improving the Compounding Unit's Quality Management System.
Key Responsibilities
- Check and release aseptically compounded products accurately and efficiently ensuring they are safe and effective for patients.
- Maintain and develop the compounding unit's QMS ensuring it is fit for purpose and complies fully with all regulatory GMP requirements.
- Deliver departmental training to ensure all staff in the unit are trained to perform the tasks relevant to their role.
- Organise and lead on planned and unplanned maintenance on compounding unit facility and equipment.
Batch Release Duties
- Ensure all finished products and starting materials meet required specifications and comply fully with GMP requirements.
- Ensure product release area is kept organised.
- Liaise with production areas whenever any clarifications are required.
- Ensure batch records and other applicable quality documents are correctly stored and archived.
Quality Management System Duties
- Responsible for the maintenance and development of the compounding unit's QMS including procedure and document control, self-inspection, change control, deviations, CAPA, complaints and product recall.
- Responsible for the update of any owned documentation.
- Ensure continuous compliance of compounding unit operations to GMP, local procedural requirements and corporate policies.
Requirements
- Strong ability to prioritise and work with a heavy workload.
- Meticulous attention to detail.
- Strong team player.
- Adapts well to change.
- Works in an organised and systematic manner.
- Finds solutions to problems.
- Copes well under pressure; demonstrates personal resilience.
- Very patient focused passionate about delivering excellence.
- Displays effective oral and written communication skills.
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