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Quality Assurance Officer

Added on:
04 Feb 2025
Contract type:
Permanent
Reference:
12680
Location:
Hertfordshire
Base Salary:
£30,000.00 P/A + Benefits

Description

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