Quality Systems Manager
- Full Time
Working in an MHRA licensed aseptic production facility.
- To develop and maintain the Pharmaceutical Quality System (PQS) compliant with EU GMP requirements as applicable to the manufacture of Specials' licensed medicines and radiopharmaceuticals.
- To plan, organize and co-ordinate the provision of analytical and environmental monitoring services from contract laboratories.
- To maintain a database of environmental monitoring results and produce monthly trend reports.
- To plan an annual programme of self inspections and participate in assigned self inspections.
- To manage a process of supplier approval.
- To perform Quality Control testing of radiopharmaceutical preparations.
- To deputise for the Head of Radiopharmacy as Quality Controller under the Specials' manufacturing licence.
- To participate in Quality Governance meetings and to provide quality metrics as defined in applicable procedures in a timely manner for review at the meetings.
- To maintain awareness of forthcoming changes to the requirements of EU GMP and to plan the implementation of all such changes.
- To participate in teaching and training including competency based training of staff and other trainees.
- Previous experience in an MHRA-licensed pharmaceutical or radiopharmaceuitcal facility.
- Previously employed in a quality assurance role either in an industrial or NHS organisation.
- Has previously participated in MHRA GMP inspections.
- Sound understanding of GMP and QA processes.
- Demonstrable experience of managing change control deviation management, supplier approval and other Quality System processes.
- Experience of undertaking internal and external GMP audits.
- Project management experience, including involvement of multi-disciplinary teams.
- Experience of formal documentation and report writing.
- Practical experience in the use of analytical equipment eg HPLC and of operations in GMP facility, or pharmarmceutical QC laboratory.
- Specialist knowledge of pharmaceutical QA and analysis.
- Knowledge and understanding of systems for quality management and quality improvement.
- Excellent knowledge and understanding of current Good Manufacturing Practice and Good Laboratory Practice requirements, and other relevant QA guidance
- Well-developed problem solving skills.
- Familiar with laboratory and environmental monitoring equipment.
- Understanding of environmental monitoring techniques and data interpretation.
- Knowledge of health and safety legislation
- Knowledge of the theory of aseptic technique and understanding of implications.
- Some knowledge of environmental micro- organisms
- Well-developed IT skills; knowledge of electronic quality management systems.
- Well developed manual dexterity and handling using personal protective equipment eg shielding devices and/or hazeaous products
- Ablity to visually examine and discriminate radiopharamaceutical products during inspection.
- Ability to perform complex QA/QC protocols/tasks accurately and timely to defined local procredures.
- Degree in appropriate science subject eg Pharmacy, Chemistry or Microbiology
- Member of relevant professional body eg GPHC, RPS, RSC, RSB
.*Must have experience in GMP Pharmaceuticals*