Site Quality Officer - QA / Validation - GMP - Pharmaceutical - UKAS - Cambridge - up to £20K

Outline of main roles and responsibilities:

Reporting to the Site Quality Manager, you will support them to ensure the maintenance of the current Quality System within the companies Laboratories (Microbiology and Chemistry) on a day to day basis.

Duties include:

· Perform daily checks on balances, pipettes, dispensers, pH meters, ovens, incubators, waterbaths, fridges and freezers, highlighting any issues/potential issues and passing completed sheets to SQM on a monthly basis for checking.
· 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 SQM of any issues/potential issues and passing completed sheets to SQM for sign off.
· Assisting with review, amendment and writing of SOP’s and responsible for issue of documents
· Ensuring that all SOP’s held by the department are current and that all relevant staff are trained accordingly in revised procedures upon re-issue.
· Assist SQM in the control of customer supplied methods and specifications.
· Initiate contact/process with new and current customers to establish Technical Agreements describing the work performed and responsibilities of the customer and laboratory, and maintain log as required.
· Archiving of departmental data and responsible for the maintenance of archive records.
· Management of departmental equipment and equipment records ensuring that all items of equipment are labelled with Group ID numbers and have an equipment record.
· Assist with investigation and documentation of departmental quality control, and proficiency testing failure reports to ensure timely submission of reports to the Group Quality Manager.
· Assist with investigation and documentation of departmental anomalies to ensure timely submission of reports.
· Assist with the completion of corrective/preventive actions arising from both internal and external audits (including UKAS, MHRA and customers) within agreed timelines.
· In conjunction with manager, ensure that departmental training records are maintained by laboratory personnel and that training record/competency reviews are performed at the appropriate frequency.
· Performance of Quarterly Compliance Checks
· Assist SQM in performing internal audits, and hosting customer audits and regulatory visits.
· Provide general QA advice and support to staff on site.

The successful candidate must have knowledge of Quality Systems, experience of UKAS and GMP requirements and preferably a pharmaceutical background. You must also have the ability to work on your own and manage projects to tight deadlines. The position is full time (40 hours per week, Monday to Friday).

Salary up to £20K + Benefits