Quality Systems Manager

Expiring today

Recruiter
Gershon Resourcing
Location
Cambridge
Salary
14.53 - 16.84 GBP Hourly
Posted
08 Nov 2019
Closes
15 Nov 2019
Contract Type
Contract
Hours
Full Time

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:

  • 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*