Position Overview & Specifications

Project QA Officer | Ceredigion - West Wales
Permanent
Bio-Pharmaceutical industry

KEY DUTIES…

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.