Salary: £35,000 – £40,000
Job Type: Permanent
Report to: Site Quality Assurance Manager
- Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality.
- Responsible for release of product from the system.
- Responsible for supporting production in the review and post compounding check operations.
- Responsible for data set up In Merlin
- Responsible for implementation and management of the companies quality system within the compound unit. Ensuring regulatory compliance.
- Ensure that unit is compliant with all corporate quality system policies and procedures.
- Responsible for review of the implementation of the companies Quality System to initiate, and drive continuous improvement
- Review, Post Compounding check and Release
- Responsible for the Review of prescriptions on Merlin
- Carrying out post compounding checks when required
- Responsible for release activities associated with products manufactured at the compounding units.
- Change Control
- Maintain a local change control process to ensure all changes are fully documented
- Ensuring all changes are assessed for risk and impact prior to implementation
- Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
- Management of the site Validation Master Plan
- Ensuring all equipment used for the manufacture and storage of product is validated before use
- Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.
- Responsible for Approval of validation protocols and reports
- GMP and Facilities and Equipment Control
- Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
- Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete
- Investigation of out of limits results using exception and CAPA processes
- Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
- Quality System Measurement and Review
- Chair monthly quality review meetings
- Ensure outcomes, decisions and actions of the review are documented
- Ensure meeting actions are completed to agreed deadlines
- Report monthly quality KPI to UK QA Manager
- Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
- Ensures all incidents reported by customers are appropriately documented and investigated
- Management of complaints using the pilgrim PMDA software
- Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper
- Reporting any adverse events to Pharmacovigilence and the Business management representative
Science degree e.g. Pharmacy, Chemistry, Microbiology or equivalent
BTech- Pharmaceutical Science or equivalent work experience
English GCSE or equivalent
Breadth & Depth of experience 2 years experience of working in a aseptic compounding operation
12 months experience of quality system implementation
Field of expertise: Ideally experience in all or any of the following:
Quality system management and implementation
Environmental / microbiological control