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Quality Assurance Officer
Purpose of the Role
To maintain and continuously improve the Compounding Unit's Quality Management System including but not limited to department SOPs, Staff Training, Trending and Reporting Environmental and Sessional Monitoring Results, Deviations and CAPAs, Change Control, Validation and Qualification
To check and release for use aseptically compounded products prepared in the compounding.
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
- With the Quality Manager - Aseptic Compounding, Production Managers and Pharmacists to 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. Ensure the facility, equipment, personnel, and processes remain in a validated state as per the site's Validation Master Plan. Collate and trend all environmental and sessional monitoring data.
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
- Support delivering product release targets, including timely batch review related activities using real time review (batch documentation, cleaning logs, preventive maintenance, calibration, etc)
- Participate in the training of releasing officer
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
- Proactively identify and support implementation of continuous improvement opportunities
- Comply with GMP, GDP, company and corporate policies and any other external regulatory requirements
- Participate in all site audits and inspections, including preparation and any associated actions
- Ensure timely communication of significant GMP and or product quality issues to management
- Ensure timely completion of all Quality System commitments
Skills & Knowledge
- Strong ability to prioritse 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 focusedpassionate about delivering excellence
- Displays effective oral and written communication skills
