Smithers is a global leader in providing scientific, technical, and regulatory services to a wide range of industries. With decades of experience, we specialise in delivering testing, consulting, and advisory services across multiple sectors, including pharmaceuticals, medical devices, automotive, and consumer products. Our commitment to excellence, innovation, and integrity has positioned us as trusted partners to clients worldwide, helping them to ensure the highest standards of safety, quality, and compliance. At Smithers, we empower our people to drive impactful results through continuous improvement and dedication to quality.
We are now seeking a highly motivated Senior Quality Officer 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. This is an exciting opportunity to work in a fast-paced environment, ensuring compliance with GMP, ISO 17025, and other regulatory standards.
Key Responsibilities:
1. Maintain and operate quality systems (GMP, ISO 17025) to ensure compliance without major issues from regulatory authorities or clients.
2. Support the Director of Quality in implementing quality policies and objectives.
3. Conduct internal audits and follow up with internal departments to ensure adherence to standards.
4. Perform Quality Assurance reviews for GMP projects, ensuring timely and thorough assessments.
5. Contribute to continuous improvement initiatives and the implementation of new systems.
6. Support non-conformance and CAPA systems as part of the overall quality assurance process.
7. Ensure health and safety compliance within the role and organisation.
Qualifications & Experience:
8. A Levels or equivalent, with training in the operation of quality systems, including audits and regulatory disciplines.
9. Relevant experience working under GMP or similar quality systems, ideally within medical or related standards.
10. Strong knowledge of ISO 17025 and auditing experience is essential.
11. A graduate qualification in a technical subject or CQI Certificate/Diploma in Quality or Lead Auditor Certification is desirable.
12. Experience with ISO 9001 and continuous improvement activities would be an advantage.
Skill & Attributes:
13. Excellent analytical skills with a strong attention to detail.
14. Proficient computer literacy and ability to follow procedures accurately.
15. Ability to build strong relationships across internal departments and external clients.
16. A proactive approach to workload management with minimal supervision.
We look forward to hearing from qualified candidates who are passionate about quality systems and regulatory compliance.
Smithers is an equal opportunity employer and welcome applications from all qualified candidates.