Senior QA Officer, Pharmaceutical
Location: Stevenage (fully onsite x5 days a week)
Type: Permanent
Salary: £35,000 - £45,000 depending on experience, with possible scope for exceptional candidates
The Role:
1. The Quality Assurance Officer will be responsible for quality management, quality assurance, and quality auditing tasks related to pharmaceutical products.
2. Ensuring products are fit for purpose before release for use or commercial sale.
3. Maintaining and improving QMS performance by managing deviations, CAPA, and change control processes in compliance with internal procedures.
4. Investigating and communicating customer or supplier complaints satisfactorily.
5. Handling customer requests and queries promptly in line with company procedures.
6. Participating in and hosting internal and external audits, including customer and regulatory audits.
7. Authoring and approving routine QMS activities.
8. Performing Root Cause Analysis using tools such as Fishbone and 5 Whys.
9. Authoring, reviewing, and approving Controlled Documents as per procedures.
10. Supporting site GMP training delivery as required.
11. Conducting internal audit programs.
12. Supporting maintenance of the site QMS and reporting relevant KPIs within the department and across the site.
The Person:
* Degree in a STEM-related subject.
* Experience in batch review and batch release.
* GMP QA experience is essential, ideally in a pharmaceutical setting or similar.
* Experience with CAPA, deviations, change controls, and internal auditing.
* Strong interpersonal and communication skills.
* Excellent written and verbal English language skills.
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