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Quality Systems Manager

Job Summary:

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.

Essential Criteria:

Experience:

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.

Knowledge:

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.

Skills:

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.

Qualifications:

.*Must have experience in GMP Pharmaceuticals*