I'm currently looking for a Qualified Person (QP) to join a Pharmaceutical consultancy business, operating remotely. As the Qualified Person, you will be responsible for releasing batches remotely, as well as the following:
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QP will be varied however the key duties and responsibilities are as follows:
1.You will liase with over-seas suppliers and manufacturers in order to deliver remote release of generic products, 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. Carry out virtual and on site audits when necessary.
4. You will need to be able to juggle multiple projects and have a good understanding of remote release and importation.
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 Generics' Pharmaceutical business
3. A working knowledge and practical experience of remote release
Key Words: Qualified Person, QP, Pharmaceutical, GMP, Audit, Generic,
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.