Overview
Job Title: Quality Operations Associate
Employment Type: Permanent, full-time
Location: Hertfordshire, UK – On-site
Role Purpose
An opportunity to join a medium-sized pharmaceutical business that specialises in Oncology and Neurology Medicines. This role is within a GMP environment and will take on the day-to-day QA activities.
The Quality Operations Associate supports Quality Systems and Quality Assurance activities across pharmaceutical manufacturing, packaging, testing, storage and distribution. The role ensures ongoing compliance with GMP, GDP, internal Quality Systems and industry standards, while supporting the effective operation and continuous improvement of the Quality Management System (QMS).
Key Responsibilities
1. Support the operation and maintenance of the Quality Management System, including Change Control, Deviations, CAPAs, Risk Management, Documentation, Training and Supplier Management
2. Support Product Quality Reviews (PQRs) and Quality Metrics reporting
3. Assist in the generation, review and maintenance of Quality Agreements
4. Support supplier approval activities and maintenance of the Approved Supplier List
5. Act as a Quality point of contact for operational departments and support the creation and progression of quality records in the eQMS
6. Review and approve batch documentation, including packaging, bulk manufacture and intermediate products
7. Support the approval and maintenance of Master Batch Records, SAP material data and Bills of Material
8. Participate in internal and external audits, including inspection readiness activities
9. Raise, assess and support the investigation of deviations, incidents, CAPAs and customer complaints
10. Support Change Control implementation and quality risk assessments
11. Assist with validation and qualification documentation review
12. Support training activities related to Quality Systems and GMP/GDP compliance
13. Support technology transfer, new product introduction and continuous improvement initiatives
14. Contribute to GDP activities, including assessment of returns and temperature excursions
15. Support annual product recall effectiveness testing
16. Identify and implement opportunities for continuous improvement and efficiency
17. Provide general quality support to other team members as required
Skills & Experience
18. 2 years of experience previously within a QA Officer type of role.
19. Minimum of a bachelors degree in life sciences.
20. Ideally prior experience working in an onsite setting,
21. Basic knowledge of Quality Systems, GMP and GDP within a pharmaceutical environment
22. Understanding of pharmaceutical manufacturing and packaging operations
23. Ability to interpret data and present clear quality conclusions
24. Strong communication and stakeholder‑management skills
25. Computer literate (Word, Excel, PowerPoint)
Key Competencies
26. Self‑motivated, professional and diplomatic
27. Strong problem‑solving and decision‑making skills
28. Effective time management and organisation
29. Able to work collaboratively within cross‑functional teams
30. Clear written and verbal communication
This role does not offer job sponsorship and requires someone based close to the site due to the nature of the role being on-site.
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