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Job Location | Newmarket |
Education | Not Mentioned |
Salary | £40,000 - £55,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time |
A highly exciting role to join one of the regions leading and fastest growing pharmaceutical businesses in a newly created post.The position will work as part of the compliance, QA and regulator affairs team.You will support a broad range of QA and CI work and we are looking for someone particularly strong on the IT & Systems side with experience implementing or working with a range of QMSs. Duties will include:• Support the compliance with national and international standards and legislations, currently ISO13485 and ISO9001 • Understanding Customer complaint investigations and trending activities• Working closely with Technical, shop floor and Business Managers to ensure manufacturing procedures and systems are sufficient to achieve and maintain current certifications• Defining and encouraging quality procedures in conjunction with operating staff.• Setting up and maintaining controls and documentation procedures, including filing and record keeping.• Liaising with customers auditors and ensuring the execution of corrective action and compliance with customers specifications.• Effectively interact with Production and Technical Support teams to maintain product supply and help introduce new products.• Working with purchasing staff to establish quality requirements from external suppliers.• Able to write, review and critique procedures and supporting documents in order that compliance is maintained.• Mentoring and coaching both within the Quality Assurance Team and throughout the business to improve the company skill-set and understanding of the QMS.• Ability to provide training and understanding of QMS procedures.We are looking for the following experience/skills:• Experience in quality management and compliance• Good interpersonal skills are essential with the ability to operate at all levels of a business • Strong systems skills with some experience with a dedicated QMS• Beneficial to have knowledge of MDR and MDSAP (not essential to apply)• Experience of continuous improvement would be beneficial.• Any experience in project management particularly on the IT and systems side highly beneficial The position offers flexi-working with a fantastic business that is expanding internationally. The working environment is supportive and fast moving, working with a great team. On offer is an excellent salary and broad range of benefits. Please apply for further info.