Senior Quality Assurance Manager
2 days ago
At Smithers, we are seeking a highly skilled Senior Quality Assurance Manager to join our Quality Team in Shawbury. The successful candidate will be responsible for maintaining Smither MSE (Europe) and Smithers MDT quality systems, conducting internal audits, supporting regulatory projects, and driving continuous improvement initiatives.
Key Responsibilities:- Maintain and operate quality systems (GMP, ISO 17025) to ensure compliance without major issues from regulatory authorities or clients.
- Support the Director of Quality in implementing quality policies and objectives.
- Conduct internal audits and follow up with internal departments to ensure adherence to standards.
- Perform Quality Assurance reviews for GMP projects, ensuring timely and thorough assessments.
- Contribute to continuous improvement initiatives and the implementation of new systems.
- Support non-conformance and CAPA systems as part of the overall quality assurance process.
- Ensure health and safety compliance within the role and organisation.
- A Levels or equivalent, with training in the operation of quality systems, including audits and regulatory disciplines.
- Relevant experience working under GMP or similar quality systems, ideally within medical or related standards.
- Strong knowledge of ISO 17025 and auditing experience is essential.
- A graduate qualification in a technical subject or CQI Certificate/Diploma in Quality or Lead Auditor Certification is desirable.
- Experience with ISO 9001 and continuous improvement activities would be an advantage.
- Excellent analytical skills with a strong attention to detail.
- Proficient computer literacy and ability to follow procedures accurately.
- Ability to build strong relationships across internal departments and external clients.
- A proactive approach to workload management with minimal supervision.
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