Description:
Element Manchester are experts in analytical chemistry and our mission is to deliver innovative, high-quality analytical expertise to our clients. An excellent opportunity has arisen for an experienced Quality Manager to join our team, based in our state-of-the-art laboratory facilities near Manchester.
The successful candidate will ensure regulatory compliance and that quality requirements, quality policies, processes and procedures are effectively implemented at all times. As a quality professional, you will promote a culture of quality assurance and quality improvement and have a sound working knowledge of cGMP or GLP.
Responsibilities
- Implement and manage all aspects of the quality system (QMS) with support from other quality team members
- Generate, review and approve relevant documentation, as appropriate, e.g., standard operating procedures, nonconforming work reports (NCRs), corrective and preventive action reports (CAPAs) and training material
- Ensure the effective implementation of MasterControl, Element Manchester’s electronic QMS
- Investigate and assign root cause(s) to any NCRs, deviations or audit findings in collaboration with colleagues
- Collaborate with operational colleagues in all areas of the business and proactively manage quality activities
- Ensuring the timely release of cGMP/GLP compliant analyses in accordance with regulatory and site-specific authorisations
- Hosting and supporting client, regulatory and accreditation body audits
Skills / Qualifications
- Quality Management experience, preferably in a fast-paced analytical laboratory or similar environment, with a minimum of three years’ experience of cGMP or GLP
- Degree or equivalent
- Internal auditing experience
- Experience hosting inspections by Regulatory Agencies such as the MHRA or the FDA or audits by National Accreditation Bodies such as UKAS
- Ability to motivate and lead a quality team would be an advantage
- Knowledge of ISO/IEC 17025, cGMP or GLP
- Experience in leading/reviewing/approving quality investigations, undertaking root cause analysis, developing corrective action plans and ensuring the effectiveness of the actions undertaken
- Ability to identify quality and technical problems, risks and opportunities for improvement and work with colleagues, at all levels, to determine effective and sustainable solutions