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