QA Officer/ Specialist - Biotechnology
* Location: Cheshire (onsite)
* Type: Permanent
* Salary: £28000-£33,000 (dependant on experience)
* Hours: Days (Monday - Friday), 08:00 - 16:30
* Parking on site
* Additional benefits: 25 days holiday + Bank Holidays, 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
* Generation or review of SOPs and other documents (where applicable)
* Providing support the customers and answering queries and product investigations
* Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses/ resolution
* Participate in the internal audit programme to ensure continued GMP compliance of all site activities
* Utilise scientific resources in order to work on improving quality of products and services
* To maintain personal training folder in an auditable state
* Maintaining quality documentation system
* Participate in quality improvement initiatives
* Supporting in the process or maintaining and archiving documentation
* Supporting and executing external audits where applicable
* Supporting management when hosting regulatory audits
* Working on executing and maintaining the QMS, including but not limited to:
o Risk Assessments
o Change Controls
o CAPAs
o Deviations
o Complaints
o Recalls
o OOS/OOT
Key Requirements
* Will have a Degree in a relevant- Scientific discipline
* Will have good knowledge of GMP
* Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous
* Strong IT skills (Microsoft applications)
* Good interpersonal skills and strong written/ verbal report writing skills
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