Site Quality Officer - Ely

Friday 11th December 2020

About the Position

Reporting directly to the Pharmaceutical Quality Manager, you will support him to ensure the maintenance of the ALS Food & Pharmaceutical Quality Management System within the Ely Pharmaceutical Laboratories (Microbiology and Chemistry) on a day to day basis.

Responsibilities: (not limited to)

  • Perform calibration of departmental pipettes and dispensers, timers and thermometers in accordance with the calibration/service schedule and mapping of incubators/ovens when required, informing the PQM of any issues/potential issues and ensuring second person sign off of completed documentation.
  • Assisting with review, amendment and writing of SOP’s and responsible for issue of documents including the control and issue of client supplied methods and specifications.
  • Ensure that all SOP’s and procedures held by the site are current and that all relevant staff are trained accordingly in current and revised procedures upon re-issue as per the group document control process.
  • Assist with and review of anomalies, complaints and OOS investigations in conjunction with Laboratory Management and the PQM and as per ALS procedures.
  • Assist with the completion of corrective/preventive actions arising from anomalies, complaints, OOS investigations, internal and external audits (including UKAS, MHRA and clients) within agreed timelines and perform subsequent effectiveness checks on those actions.
  • Initiate contact/process with new and existing clients to establish Technical Agreements describing the work performed and responsibilities of the client and laboratory, and maintain records as required.
  • Initiate contact/process with new and existing suppliers/subcontractors to evaluate their suitability for use by ALS.
  • Review and audit protocols and reports for technical project work, method transfers and development / validation of methods.

About you:

To be successful in this role you will have:

  • A scientific background (degree level) where analytical skills can be used for problem solving solution.
  • A good understanding of Quality Management Systems, UKAS and GMP requirements.
  • The ability to work on your own and manage projects to tight deadlines with a good understanding of the laboratory methods and techniques.
  • Excellent communication and interpersonal skills.
  • Good understanding of the Pharmaceutical Industry and clients’ needs.
  • Good computer literacy skills.
  • High level of reporting and writing skills.
  • Excellent organisational skills and the ability to multi-task.
  • Very high attention to detail and a methodical approach.

This is an excellent opportunity for a motivated and skilled person looking to develop their career in an international company. Attractive remuneration and benefits can be available dependant on performance.

If you are interested in applying for this role, please send a cover letter and CV to [email protected]