Hobson Prior are seeking a Qualified Person to join a world-leading drug development organisation at their Nottingham facility. Our client focuses on the early stage development of small molecule drug candidates from bench to clinic. This role will be primarily to release batches of Investigational Medical Products to clients or the clinic according to 2001/83/EC as amended.
- Accountable to perform all legal duties as defined in 2001/83/EC as amended.
- Responsible for all routine duties as defined in 2001/83/EC as amended (QP Release/Certification of IMP batches to Clients/Clinic).
- Contributes in the auditing of all contractors and suppliers.
- Reviews all manufacturing Batch Records for each IMP batch including batch related deviations.
- Reviews Pharmaceutical Quality Systems used such as Change Control, Corrective Action Preventive Action (CAPA), Internal Audit, non-conformance, Quality Agreements and ensure compliance with site SOPs.
- Assist with site Client Audits or Regulatory Inspections.
- Partake in Product Quality Reviews.
- Responsible for any Product Recall.
- Deliver support for the materials management approval process, including performing risk assessments and audits as required.
- You will make sure that all work is conducted in a responsible and safe manner in accordance with Molecular Profiles Health and Safety policies and ensure that all Health and Safety considerations are appropriately documented.
- Leads with Integrity and Respect.
- Delivers Results.
- Demonstrates Business Acumen.
- Fosters collaboration and teamwork.
- Engages and Inspires.
- Degree in a science-based subject.
- A strong understanding of Good Manufacturing Practice, Quality Systems relating to Pharmaceutical Development and Manufacturing of clinical trial products.
- Knowledge of EU and US GMP regulations.
- Trained to conduct audits, internal and external to required GMP standards.
- Prior experience of Client/Regulatory audits.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.