At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.
Quality Assurance Officer
Reading | United Kingdom (GB) | Full-time | Permanent
This role will be based at our office in Reading, with the requirement to attend the office on Mondays, Tuesdays and Thursdays.
OBJECTIVE
To be responsible for Quality Assurance (QA) data checking in support of pharmaceutical and QMS activities whilst ensuring all associated documentation is accurate and QA reviewed. Such documentation used to support manufacturing, batch disposition, stability or regulatory submission packages.
KEY ACCOUNTABILITIES
1. Provide support for day-to-day operation of the Quality Assurance department.
2. Operate in accordance to GMP.
3. Deliver direct quality team support during customer and regulatory audits.
4. Assist in third party audits as required.
5. Support the collation, processing, review and trending of quality complaints, process deviations, non-conformances, QMS actions and change controls.
6. Collate Annual Product Quality Reviews for QP review and approval.
7. Participate in Self-Inspection audits of Britannia Departments including Quality Assurance.
8. Collate and review batch release documentation for medical devices and medicinal products.
9. Issue, maintain and archive GxP documentation in accordance with company Documentation Management System.
10. Populate QMS metrics.
11. Provide support to internal and external customers as required.
12. Adhere to company documentation policies and maintaining documentation systems as required.
13. Responsible for working in accordance with our compliance procedures, legislation and regulatory requirements at all times. This includes, but not limited to, directives and guidance such as PMCPA, NMC, APBI Code of Practice, GMDP and other GxPs
PERSONAL SPECIFICATION
Essential
14. Scientific background either via experience or qualification.
15. Excellent oral and written communication skills.
16. Must be a self-starter who can take general concepts and direction and produce desirable results.
17. Proficient in use of various computer software, such as Microsoft Word, Excel and PowerPoint.
18. Demonstrate attention to detail.
19. Experience within manufacturing environment with demonstrated ability to understand process or technical documentation.
20. Able to prioritise workload, decisive thinker able to work within agreed timescales.
21. Ability to work both independently and as a team member.
22. Solid understanding of applicable EU Regulations, Directives and Guidance pertaining to GMP and GDP.
Desirable
23. Experience of working within a Medical device, GMP, ISO 9001 or ISO 13485 background
24. Internal auditor trained / experienced
25. Experience of reviewing/ updating production documentation, SOPs or similar.
26. Demonstrated working knowledge of compliance, quality and manufacturing documentation requirements
27. Experience in use of eQMS systems