Job Reference: J5636080
Updated On: 01/06/2022
Status: Open to Applications
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Role OverviewI’m currently looking for a Qualified Person (QP) to join a Global Biotech business based in the Wiltshire area. As the Qualified Person, you will be responsible for the following:
Key Duties and ResponsibilitiesKEY DUTIES AND RESPONSIBILITIES:
Your duties as the QP will be varied however the key duties and responsibilities are as follows:
1. You will report directly to the Lead QP, working as part of the QP team, assisting with the throughput of manufacturing documentation & batch deviations, ensuring that all batches meet the necessary marketing and manufacturing authorisations.
2. Review of batch records and disposition of batches as a Qualified person under EU directives (2001/82 & 2001/83), ensuring compliance with the site MIA/MIA(IMP) and ensuring the batch has been manufactured in accordance to the relevant GMP guidelines as stated in Directive 2003/94/EC (human).
3. Ensure any deviations in packaging, quality procedures or manufacture processes are notified in accordance with the required reporting system and investigated before any impacted batch is released.
4. To provide technical support to the team of QA Officers and other key contacts including but not limited to production and quality personnel. Including providing guidance, support and direction on Quality related matters within the business as required.
To be successful in your application to this exciting opportunity as the Qualified Person, I’m looking to identify the following on your profile and past history:
1. Relevant experience as a Qualified QP
2. Proven industry experience within a Biotechnlogy business
3. A working knowledge and practical experience of ATMP’s, Sterile or Aseptic manufacturing environments.
Key Words: Qualified Person, QP, Biotechnology, ATMP, Pharmaceutical, GMP
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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