Job title: Microbiology Compliance Officer Department: QC Department Locations: Porton Down, Salisbury Salary: Starting salary £27,000 negotiable dependent upon experience Hours: 37.5 Job Type Permanent Our client has approximately 350 staff, performing a range of process and analytical development, production, quality control and quality assurance roles associated with the development and manufacture of biopharmaceuticals. The department carries out the manufacture of Erwinase and Anthrax Vaccine, as well as contract manufacturing projects. The purpose of this role is to provide support for the QC Microbiology department .This will include compilation of compliance documentation, including deviations, non-conformances and CAPA, change controls, protocols and reports. The holder will also to undertake and perform microbiological QC analyses in compliance with cGMP. The Job * Write and review Standard Operating Procedures, protocols and reports in accordance with regulatory requirements. * Investigate, write and review non-conformances and deviations raised in accordance with regulatory requirements. * Complete departmental CAPAs and to implement any required quality improvements that may arise from this. * Identify and implement quality improvements within the department pro-actively. * Carry out change management, raising, writing and reviewing change controls. * Assist as a member of the QC Microbiology Team, on a day to day basis, of the Bacteriology Technical Services Unit. * Test microbiological samples, working at ACDP Containment level 2 and at Containment Level 3, when required, from all stages of the production processes of products manufactured at PBL, Porton Down and to assess the results against pre-set standards. * Record and assess results from environmental and water sampling and carry out preliminary and confirmatory identification of micro-organisms. The ideal candidate A candidate with significant experience of working to cGMP, with a significant knowledge of pharmaceutical Quality Assurance. The candidate must have experience in writing and reviewing discrepancies, procedures, change controls and CAPAs. The candidate should have a significant level of experience of working within ACDP containment level 2 microbiology laboratories
JOB SUMMARY
Location
Porton, Wiltshire,United Kingdom
Job Type
Permanent
Salary
£27000.00 - £27000.00
Posted
2019-12-02
Educational Level
Notavailable
Career Level
Notavailable
Company Name
Address
Porton, Wiltshire,United Kingdom
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