Quality Assurance Officer, Pharmaceutical
Location: Widnes, (this is an onsite role and duties cannot be performed from home).
Type: Permanent
Hours: Working 9-17.30 Monday to Friday
Additional: 25 days +BH hols, company bonus scheme (dependant on performance), company pension, onsite parking
Major Duties and Responsibilities
1. Reviewing Batch records and creating the associated checklists to support batch certification.
2. Archiving GMP critical documents in line with company policy.
3. Ensuring current versions of controlled documents are available to site personnel.
4. Assist in Audits.
5. Proactively identifying risks within the QMS and supporting the development of action plans to address and drive continuous improvement.
6. Fostering collaborative working with sister departments across the globe.
7. Performing out of specification / out of trend investigations.
8. Performing deviation / complaint investigations.
9. Assisting in the follow up of events and CAPA's.
10. Ensuring correct QC samples are taken and sent for UK release testing in a timely manner.
The Person
1. Minimum degree in pharmacy, biomedical sciences, or any other scientific degree.
2. 2 years' experience in a GMP/GLP role.
3. Experience in CAPA, OOs, OOt, deviations, change controls etc in a GMP setting.
4. Willingness to learn.
5. Strong administrative skills and the ability to generate clear and concise communication across all departments.
6. Ability to prioritize work, take initiative when required and to work quickly and accurately.
7. Attention to detail.
8. Ability to work in a fast-paced, small company environment.
9. Great interpersonal skills, a team player but equally comfortable to work independently.
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