Qualified Person

About – Scienta are teaming up with the top UK Clinical Research Organisation. They are working on Phase I-III studies, with great success in Oncology and Rare Disease Therapeutic areas. They have worked on over 400 clinical studies are not looking to stop there – currently they are expecting this trajectory to carry on and reach 500 by close of 2023, so plenty of work to be done.

They are now looking for a Junior QP to join the team! Someone who has recently qualified and looking for extensive learning opportunities and a chance to truly express their talent is the key for this position – hunger and determination goes a long way in this type of environment.

Your role –

• Complete QP duties as laid out in Directives 2003/94/EC, 2001/20/EC, and 2001/83/EC and UK SI 2004/1031
• Mainly responsible for Certifying IMP batches for Release in clinical Trials.
• Responsible for QP oversight for the import of IMPs from Listed countries
• Carry Out functions related to GMP Quality compliance objectives.
• Ensure compliance to Quality System
• Promote Quality Culture, Identify GMP Quality improvements and enable implementation of continuous improvement initiatives.
• Work effectively with RPL Customers to set new supply chains and provide end to end QP support during the conduct of sponsor clinical trials.
• Ensure Processes within your area of responsibility fully meet regulatory, business and customer expectations and targets.
• Actively participate in the Site Quality council; present compliance t GMP Quality Objectives and the key issues impacting GMP Quality

Your Profile –

• Qualified person in accordance with Directive 2001/20/EC., and/or Qualified person in accordance with Directive 2001/83/EC.
• BSc/MSc in Pharmacy or relevant scientific discipline
• Experience in IMP and Clinical trial, preferably in Phase 1 environment
• Experience within a GCP and/or GMP site of ~5+ years

Why Apply?

If you are looking to work within a dynamic, and rewarding environment, then this is the ideal role for yourself. This is an opportunity to be a part of an extremely well established CRO which is a fantastic next step for career progression and exceptional knowledge to be gained.

Please submit your CV to us for a private and confidential discussion about the opportunity.