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