QA Officer/ Specialist - Biotechnology
Location: Cheshire (onsite)
Type: Permanent
Salary: £25000-£32000 (dependant on experience)
Hours: Days (Monday - Friday), parking onsite
Additional: 25 days holiday + BH, private medical, share options scheme, company pension
Our Client a Biotech company is looking to strengthen their QA team and recruit an experienced QA Specialist.
The role:
1. Generation or review of SOPs and other documents (where applicable)
2. Providing support to customers and answering queries and product investigations
3. Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses/ resolution
4. Participate in the internal audit programme to ensure continued GMP compliance of all site activities
5. Utilise scientific resources in order to work on improving quality of products and services
6. Maintain personal training folder in an auditable state
7. Maintain quality documentation system
8. Participate in quality improvement initiatives
9. Support in the process of maintaining and archiving documentation
10. Support and execute external audits where applicable
11. Support management when hosting regulatory audits
12. Work on executing and maintaining the QMS, including but not limited to:
1. Risk Assessments
2. Change Controls
3. CAPAs
4. Deviations
5. Complaints
6. Recalls
7. OOS/OOT
The Person:
1. Will have a Degree in a relevant Scientific discipline
2. Will have good knowledge of GMP
3. Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous
4. Strong IT skills (Microsoft applications)
5. Good interpersonal skills and strong written/verbal report writing skills
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