Project QA Officer | Ceredigion – West Wales
- Accountable for QA oversight of the external manufacturing operations to ensure the corresponding GMP compliance in every phase according to regulatory expectations.
- Provide guidance and supporting external manufacturing with Product Disposition;
- cGMP Document Review – including reviewing both master and executed Batch Manufacturing Records, validation/qualification protocols and reports
- Coordination/support for batch release
- Arranging, attending, taking minutes from calls with CMOs/CTLs
- Review and approve External Investigations and ensure issues are tracked within company QMS system
- Ensure escalation of substantial issues to the Quality Assurance Lead;
- Preparing and executing the external auditing program.
- Ensuring that GXP rules are obeyed adequately to the project stage.
- Preparation and review of Quality Agreements.
- Review, analysis and approval the change controls, product release test results, , lab investigation reports, and manage OOS investigation etc.
WHAT YOU WILL NEED…
- Science degree including – Biology, Microbiology, Biochemistry, Pharmacy, Chemistry or Biotechnology (or equivalent) is preferred.
- Experience dealing directly with both regulatory agency personnel as well as the CDMO provider representatives is preferred.
- Experience in operational GMP in a pharmaceutical manufacturing environment including batch disposition is desirable.
- An experience in Quality or Quality Assurance functions within the Pharmaceutical or Medical Device Industry is required is preferred.
- Understanding of the regulatory/Quality responsibilities active pharmaceutical ingredient (DS) and drug product (DP) batch disposition.
- Demonstrated negotiation and influencing skills.
- Knowledge of MS Word, Excel, PowerPoint and data management platforms.
- Willing to travel within UK, EU and internationally for up to 15% of time
- Strong written, verbal and presentation skills.
- Join a friendly, supportive team
- Company bonus scheme
- Private healthcare
- Excellent Pension & holiday allowance