Device Quality Systems Officer
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Quality Assurance Officer
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Hyper Recruitment Solutions are currently looking for a Quality Compliance Specialist to join a leading Bio-Pharmaceutical company based in the Hertfordshire area. As the Quality Compliance Specialist you will be responsible for ensuring GMP compliance by liaising with key suppliers and performing internal regulatory inspections.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Compliance Specialist will be varied however the key duties and responsibilities are as follows:
1. You will take ownership of Supplier Quality Assurance, writing and reviewing technical quality agreements, responding to customer and third party inspections, and performing supplier quality audits.
2. The Quality Compliance Specialist will perform internal audits and give key feedback to Senior Managers of GMP and GLP compliance of the manufacturing site and its associated systems.
3. You will communicate with both internal departments and suppliers to ensure GMP compliance across all business areas. This will involve reviewing key processes and suggest improvements to Quality Duties including the batch release process, CAPA implementation, OOS results and change controls.
4. As the Quality Compliance Specialist you will provide a key point of contact with regulatory agencies to review production issues and queries. You will lead meetings between departments to maintain cGMP compliance.
To be successful in your application to this exciting opportunity as the Quality Compliance Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific subject.
2. Proven industry experience in a pharmaceutical or laboratory based environment, with expert knowledge in GMP regulations covering Europe and the United States.
3. A working knowledge and practical experience with conducting internal and external regulatory audits to GMP standards would be desirable. Experience working in a sterile manufacturing environment would be advantageous.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.