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