Overview
Quality Assurance Officer - High Wycombe (Hybrid)
Ethypharm is a European pharmaceutical whose mission is to improve patients’ lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine.
Are you passionate about quality and compliance in the pharmaceutical industry?
We’re looking for a motivated Quality Assurance Associate to join our team and support the QA Manager and Qualified Person. You’ll play a vital role in maintaining and improving our Virtual Plant Quality Management System (QMS), ensuring that our partners meet the highest standards of GxP compliance. This is a fantastic opportunity to be part of a collaborative environment where your expertise will make a real impact.
Responsibilities
* Ensure the Virtual Plant Quality Management System is fully in place and consistently followed.
* Act as process owner for allocated QMS elements, ensuring alignment with current GxP guidelines.
* Manage assigned CMOs or distribution partners from a Quality perspective – covering technical agreements, product quality reviews, product quality complaints, vendor complaints, deviations, CAPA, change controls, temperature excursions, artwork, risk assessments, and documentation approvals.
* Attend and actively contribute to supply chain meetings with CMOs or partners.
* Collate and review KPI data to demonstrate compliance and effectiveness.
* Contribute to Quality Review Group (QRG) presentations.
* Create, update, and review SOPs to ensure operational excellence.
* Drive continuous improvement by identifying efficiencies in processes.
* Work cross-functionally within multidisciplinary project teams.
* Carry out additional quality-related tasks as needed (with full training provided).
Qualifications
You are detail-oriented, methodical, and thrive on ensuring compliance in a fast-paced environment. You enjoy collaborating with partners and colleagues, and you’re not afraid to take ownership of processes. With strong problem-solving skills and a diplomatic approach, you can confidently balance quality standards with business needs.
* Degree level education (Science-based preferred).
* Strong understanding and experience of Pharmaceutical Quality Management Systems in line with ICH Q10.
* Internal and/or external auditing experience.
* Knowledge of Good Manufacturing Practices (GMP).
* Understanding of ICH Q1 requirements for stability testing.
* Well-developed IT skills (MS Office or equivalent).
* Excellent communication and interpersonal skills.
Benefits
At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business. Visit our website at www.ethypharm.com to learn more about Ethypharm.
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