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Hyper Recruitment Solutions are currently looking for a Senior Quality Specialist (New Product Introduction) to join a leading Pharmaceutical company based in the Cambridgeshire area. As the Senior Quality Specialist (New Product Introduction) you will be responsible for ensuring GXP compliance and assessing risks associated with introducing new products into defined supply chains.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Quality Specialist (New Product Introduction) will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for ensuring new product introduction is carried out in accordance within current regulatory guidelines and all relevant marketing/manufacturing authorisations. You will require a strong understanding of external quality compliance/supply chain assurance, and be required to support with technical and method transfer projects relating to NPI projects.
2. You will act as the Quality representative during the due diligence process in multiple projects following the identification of new business opportunities including product acquisitions and licence and distribution deals. The Senior Quality Specialist (New Product Introduction) will be accountable for the Quality decisions and actions on projects that they represent.
3. The Senior Quality Specialist will maintain excellent knowledge of relevant regulatory guidelines as well as knowledge of Quality Requirements for all product platforms across different business areas (R&D, In licensed and New Acquisitions).
4. As the Senior Quality Specialist you will be responsible for liaising with third parties and internal departments to ensure that the risk is properly assessed during the due diligence process, you will provide technical expertise to multiple projects as they enter full scale manufacturing.
To be successful in your application to this exciting opportunity as the Senior Quality Specialist (New Product Introduction) we are looking to identify the following on your profile and past history:
1. A strong understanding of current GMDP guidelines (EU,FDA,WHO,ICH,PIC/S), a GMDP auditor accreditation would be advantageous.
2. Proven industry experience in a range of manufacturing processes working in GXP compliant industries, with experience dealing with Third Parties.
3. A working knowledge and practical experience with CTD/Regulatory requirements along with Tech/Method transfer experience would be advantageous.
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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.