Job Reference: J5632316
Updated On: 07/10/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a QC Micro Compliance Officer to join a leading Biopharmaceutical company based in the Wiltshire area. As the QC Micro Compliance Officer you will be responsible for providing 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.
Key Duties and Responsibilities1. You will write and review SOPs, protocols and reports in accordance with regulatory requirements. Additionally, you will be responsible for completing departmental CAPAs and implementing any required quality improvements that may arise from this.
2. As the QC Compliance officer you will be responsible for testing 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 and to assess the results against pre-set standards.
3. You will also be expected to prepare environmental monitoring consumables for production areas in an aseptic manner on a daily basis and to pre-test this media, along with that to be used in the Unit and other areas against pre-determined standards to ensure appropriate performance.
4. You will maintain the culture collection, media stocks and necessary consumable supplies to ensure the efficient running of the Unit during normal production activities.
Role Requirements1. Relevant degree in a Life Sciences or Microbiology related subject plus industry experience.
2. Proven industry experience working in a Quality Management System, and working knowledge of CAPA, change management and quality risk management.
3. A working knowledge and practical experience of GMP.
Key Words: Quality Control, Compliance, Microbiology, Life Sciences, BioPharmaceuticals, GMP, cGMP, ACDP, CAPA, Change Control.
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