Qualified Person (QP)
Catalent Pharma Solutions are looking to recruit an experienced Qualified Person (QP) to join our team at our Nottingham site.
The role of QP is primarily to release batches of Investigational Medical Products (IMP) to clients or the clinic according to 2001/83/EC as amended.
In the role of QP you will ensure that all manufacturing steps are performed in accordance with 2003/94/EC and Eudralex Volume 4.
- 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
- Participates 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, CAPA, Internal Audit, non-conformances, Quality Agreements and ensure compliance with site SOPs.
- Support site Client Audits or Regulatory Inspections.
- Participate in Product Quality Reviews.
- Responsible for any Product Recall.
- Provide support for the materials management approval process, including performing risk assessments and audits as required.
- Ensure that all work is conducted in responsible and safe manner in accordance with Molecular Profiles Health and Safety policies and ensure that all Health and Safety considerations are appropriately documented
- Eligible to act as a QP in the UK
- A degree in a science-based subject
- An in-depth understanding of GMP 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
- Experience of Client/Regulatory audits
Our 7 standard leadership competencies
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Competitive salary
- Discretionary annual bonus
- Contributory Pension scheme
- 25 days holiday – plus bank holidays
- Life Assurance
- Healthcare provision
- Free parking
- Childcare vouchers
- Health Shield
- Learning & Development opportunities
To apply email Iain.Macdonald@catalent.com.