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Quality Assurance Officer - Project
🏢 Sunny
Work Model
📍 Bangor Teifi, Wales
Employment
💼 Full-Time Direct
Recruitment Type
🛡️ Direct to HR Pipeline
Role Overview & Responsibilities
- Located in a beautiful part of Wales
- Willing to travel within UK, EU and internationally for up to 15% of time
- Excellent salary incl private healthcare etc.
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.
BENEFITS…
- Join a friendly, supportive team
- Company bonus scheme
- Private healthcare
- Excellent Pension & holiday allowance
IND123
Frequently Asked Questions
How do I apply for the Quality Assurance Officer - Project position at Sunny?
Click the “Apply for this Position” button on this page to submit your details directly to Sunny's recruitment pipeline without agency fees or intermediaries.
Is this role eligible for remote work or international relocation?
This position is based in Bangor Teifi, Wales with potential relocation and visa sponsorship considerations for qualified candidates.
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