J4750CambridgeshirePharmaceutical Biotechnology CRO/CMO Permanent£65,000 to £85,000 per annumFull Time02/01/2018Quality Assurance Quality Assurance – Qualified Person (QP) Quality Assurance – Auditing Quality Assurance – Compliance Quality Assurance - Validation Quality Assurance – GMP Quality Assurance - GDP Quality Assurance - GxP
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We are currently looking for a Quality Systems Manager to join a leading Pharmaceutical company based in the Cambridge area. As the Quality Systems Manager you will be responsible for driving the vision and development of site wide Quality Systems, ensuring compliance throughout the life cycle of the pharmaceutical manufacturing process.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Systems Manager will be varied however the key duties and responsibilities are as follows:
1. You will help support the implementation of the newly designed Quality Systems, ensuring compliance to regulatory and company standards. You will need to help influence teams driving change.
2. As the Quality Systems Manager you will manage a Quality Assurance team whose sole responsibility is to ensuring QMS compliance, therefore people management experience is key.
3. You will oversee projects from a Quality Assurance perspective. This will include working with new and existing suppliers and partners, ensuring that they are compliant to the correct Quality standards that you require. This includes timely escalations and investigations, ensuring effective root cause investigations, CAPA processes and all round QMS management.
4. You will liaise with Senior Managers and Business Leaders, informing them of site data, risks and actions. As the Senior Manager, you will inform them of project status, providing full data and QMS status. Therefore, you will require a certain gravitas about you.
To be successful in your application to this exciting opportunity as the Quality Systems Manager we are looking to identify the following on your profile and past history:
1. Prior experience managing and developing a site wide Quality System within a pharmaceutical manufacturing site is essential. Any experience implementing or building a new Quality System or acting as a Qualified Person (QP) would be highly beneficial.
2. Previous experience managing a Quality Assurance team is needed. The position will have a vast amount of team and stakeholder management.
3. A working knowledge and practical experience with regulatory guidelines. As a minimum, you will have worked with MHRA with any EMA or FDA experience being desirable.
Key Words: Quality Assurance | Quality Manager | QA | Quality Systems | QMS | Quality Systems Manager | MHRA | FDA | EMA | Pharma | Implementation | Management | GMP | GDP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.