QA Officer - Pharmaceutical - QMS- QC - GMP - Cambs - £20k-£22k - OOS - CAPA - Audit - Temperature Monitoring - Equipment Checks
A leading contract testing laboratory requires a QA Officer to join its pharmaceutical division. Your role will be to support the quality manager with all QA activities on a day to day basis. You must have a good understanding of quality management systems and worked in a quality assurance or quality control focused role previously (Ideally in a pharmaceuticals)
Reporting directly to the Pharmaceutical Quality Manager, you will support her to ensure the maintenance of the Quality Management System within the Pharmaceutical Laboratories (Microbiology and Chemistry) on a day to day basis.
*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 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.
*Management of anomalies, complaints and OOS investigations in conjunction with the Laboratory Management and as per Group 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 subsequently perform effectiveness checks on those actions.
*Initiate contact/process with new and current clients to establish Technical Agreements describing the work performed and responsibilities of the client and laboratory, and maintain log as required.
*Review and audit protocols and reports for technical project work, method transfers and development / validation of methods.
*Archiving of laboratory data and responsible for the maintenance of archive records.
*Management of equipment and equipment 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 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.
*Management of quality control failures, proficiency testing failures and internal non-compliances in conjunction with the Laboratory Management and as per Group procedures.
*Work closely to support PQM and other members of the site Quality Team in the Quality function, ensuring all requirements are met and delivered on time, and reviewing procedures and systems regularly for continuous improvement.
*Perform Technical and Quality audits as well as laboratory inspections on site and at other sites upon request, and assist the PQM in hosting client audits and regulatory inspections.
*Provide general QM advice and support to staff on site.
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.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Posted: 28th July 2017
- Expires: 25th August 2017
- Reference: BBBH4918