A contract testing laboratory is looking for a Site Quality Officer to join its growing team. You will be responsible for supporting the Pharmaceutical Quality Manager to ensure the maintenance of the Quality Management System in a Microbiology and Chemistry lab on a day-to-day basis. To apply for this role, you must hold a degree in a scientific discipline and have an interest in detail and quality.
- 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 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.
- Review and audit protocols and reports for technical project work, method transfers and development / validation of methods.
- Archiving of laboratory records and responsible for the maintenance of archiving records.
- Ensuring that all items of equipment are correctly recorded, labelled, and are calibrated at the appropriate frequency in accordance with the site calibration/service schedule
- In conjunction with the PQM and laboratory management, ensure that departmental training records are maintained by laboratory personnel and that training record/competency reviews are performed at the appropriate frequency.
- Assist with and review of quality control failure, proficiency testing failure and internal non-compliance investigations in conjunction with Laboratory Management and the PQM and as per procedures.
- Work closely to support the PQM and other members of the site Quality Team, ensuring all requirements are met and delivered on time, and reviewing procedures and systems regularly for continuous improvement.
- Perform internal audits and laboratory inspections on site and at other sites upon request.
- Assist the PQM with fulfilment of data integrity compliance requirements.
- Provide general QM advice and support to staff on site.
- 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 a great opportunity for either a graduate looking to enter a quality focused role, or someone with QA experience looking to progress their career in a growing, successful company. Apply now.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 6729
- Posted: 6th January 2021
- Expires: 3rd February 2021