The role of the Qualified Person is integral to the success of the Quality Department in delivering expert advice and ensuring release of clinical/commercial supplies, in line with customer expectations and regulatory demands. The Qualified Person will ensure that finished products are not released until their quality has been judged to be satisfactory as measured against specifications and regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
The duties of the Qualified Person / QP are broad and a detailed job description is available on request. An example of such duties include:
1) Act as a Qualified Person under EU Directive 2001/20/EC for the release of batches imported to or processed, fulfilling the requirements specified in article 13.3 and undertaking the duties outlined in Annex 13.
2) Determine the requirements for, and level of release necessary for materials handled, including the release of just-in-time labelled material for despatch.
3) Evaluate study supply chains and assess, as applicable, each site involved to ascertain compliance with standards at least equivalent to EU GMP. Audit manufacturing and testing sites as well as compiling audit reports to a high standard in accordance with the relevant procedure.
The successful Qualified Person / QP will need to demonstrate the following in their profile to be considered:
1) Degree in a relevant scientific discipline and be eligible to be appointed as Qualified Person under the permanent provisions to our client\'s license.
2) Experience in undertaking the routine duties of a Qualified Person as well as experience in auditing suppliers, API facilities, drug product manufacturing or testing sites and exposure to more than one dosage form (steriles/biologics would be advantageous)
Key Words: Qualified Person / QP / Quality Assurance Professional / Batch Release / GMP Quality / Quality Assurance / Contract /
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.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Haseena Mooncey
- Phone: 0203 910 2980
- Reference: J5634413
Website: Hyper Recruitment Solutions
- Posted: 5th February 2021
- Expires: 5th March 2021