Senior QA Officer, Pharmaceutical
Location: Bolton/ North Manchester area
Type: Permanent
Hours: Days (Monday - Friday), parking onsite
Responsibilities:
1. Duties will include handling site quality issues including compliance, validation, internal audits, project management & execution, and quality documentation, under the leadership of the Quality Assurance Manager.
2. This role involves overseeing the quality of all products manufactured or sourced by the company to ensure adherence to GMP, GDP, and documented procedures.
3. Additionally, the role supports Quality Management in implementing GMP/GDP documentation and in enhancing the Quality Management System (QMS) for continuous improvement.
4. CAPAs, Deviations, audits, risk assessments, customer complaints & root cause analysis.
5. Generate SOPS and other quality documentation.
6. Ensure that the QMS is already in a condition ready to inspect.
7. Ensure that the internal audit schedule is followed as per procedure.
8. Manage and maintain the supplier approval process.
9. Create supplier audit documentation.
10. Liase with MHRA relating to quality and compliance matters.
11. Assist in training of QA team members as well as potentially helping to support other teams.
12. Undertake and develop risk assessments.
The Person:
1. Good knowledge of GMP/GDP related pharmaceutical manufacturing.
2. 3 years+ GMP experience in a similar facility.
3. Experience in CAPA, deviation, change controls, OOs, Oot etc.
4. Demonstrated compliance with procedures and policies.
5. The ideal Candidate will have auditing experience (desired).
6. Excellent team, interpersonal skills, and communication skills (both written and verbal).
7. Willingness to work flexible hours.
8. Safe adoption of working practices together with an understanding of the needs for precise and accurate documentation.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us.
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