Quality Assurance Officer - Project
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Position Overview & Specifications
- 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
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
United Kingdom Right to Work & Skilled Worker Visa Guide
Employment in the United Kingdom requires legal Right to Work verified under the Home Office Points-Based Immigration System:
Sponsoring employers must hold an active Home Office A-rated Sponsor License and assign a valid Certificate of Sponsorship (CoS). Role must meet the general minimum salary threshold (£38,700) or occupation going rate.
Continuous employment under Skilled Worker status establishes eligibility for Indefinite Leave to Remain (ILR) after 5 continuous years, leading to British Citizenship.
Candidate Preparation Blueprint: General
Based on transatlantic hiring benchmarks for Quality Assurance Officer - Project roles across Sunny's corporate sector, successful applicants typically excel across three core dimensions:
Demonstrated portfolio evidence, architecture/system design case studies, or validated professional certifications directly applicable to General.
STAR method competency responses highlighting cross-functional leadership, conflict resolution, and delivering measurable enterprise ROI under tight timelines.
Total compensation expectation aligned within the benchmarked £37,000 - £60,000 bracket, including retirement vesting and health parity.
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