Quality Assurance Officer

Well Established Pharmaceutical CMO is Seeking to add to the Quality Team by Recruiting a Quality Assurance Officer, who Will Work Full Time, On-Site, at a State-of-the-Art Facility in a Highly Conducive Environment ROLE * Controlling and Amending Master BPR’s and BAR’s * Preparation of Product Quality Reports * Controlled Document Management * Authoring and Reviewing Controlled Documents eg Manufacturing Logs, SOP’s * Reviewing and Approving Batch Record BOM’s, (Work Orders) * Vendor Management, Collection of Required Quality Documents * Management of Technical Agreements * Artwork Proofing and Management, Including Liaison with Regulatory Affairs and Third Parties * Risk Assessments and Gap Analysis * Managing Monthly KPI’s * Contributing and Assisting in Regulatory Inspections and External Audits * Raising and Assessing Deviations, Change Controls and CAPA’s * Reviewing Specifications, Methods and Ensure Effectiveness * Handling Supplier Complaints * Reviewing BOR’s to Ensure Conformance with Registered Licenses * Ensuring Self-Inspections are Performed at Appropriate Regular Intervals, and Necessary Corrective Measures Introduced * Supporting Regulatory Team, with Compilation of CTD Modules, Prior to MHRA Submissions * Ensuring Established Quality Management System is Maintained and Sufficient for Accreditations Held REQUIRED * Bachelor’s Degree (or Equivalent) in Relevant Field * Minimum 3 Years QA Experience, Working in the Pharma Sector * Sound Knowledge of Quality Assurance Terminology, Methods, and Tools * Excellent Computer Skills, Including Database Management * Analytical, Problem-Solving, and Decision-Making Skills