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Quality Assurance Officer
Job Posted: a month ago
Salary: £ 32,000/Annum
Job Type: Permanent
Location: Hatfield, Hertfordshire
Expire in: 7 hours
Job 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 SkillsBefore You Apply
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