Job Reference: J5635280
Updated On: 18/08/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a Quality Systems Specialist to join a leading CDMO based in the Oxfordshire region. As the Quality Systems Specialist you will be responsible for leading Quality Systems improvement projects across the site, as well as the following:
Key Duties and ResponsibilitiesKEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Systems Specialist will be varied however the key duties and responsibilities are as follows:
1. Assess and ensure efficient optimisation of the quality processes, identifying processes that can be improved or streamlined, updating tools and associated procedures accordingly. (CAPA's, Deviations, Change Controls, Validation etc.)
2. Promotes and contributes to Continuous Improvement activities, identifying lean alternatives across the business.
3. Responsible for decisions related to GMP compliance, ensuring activities within the area are aligned with the company policies & working with the GMP training team to advise on new or improved quality processes, systems or tools.
4. Provides required support during client audits and regulatory inspections.
Role RequirementsROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Quality Systems Specialist we are looking to identify the following on your profile and past history:
1. Experienced working with Quality Systems within a pharmaceutical GMP organisation.
2. Proven industry experience within a GMP environment with good knowledge of the regulation.
3. A working knowledge and practical experience of Lean Six Sigma.
Key Words: QMS, Quality System, Quality Assurance, GMP, Lean, Quality Processes.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 recruitment professionals and scientists. We look forward to helping you with your next career moves.
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