Job Opportunity: Qualified Person (QP) for Investigational Medicinal Products (IMPs)
Location: Midlands across a couple of factories
INSIDE IR35 ONLY
Interim: 6-12 months, flexible for part time 3-5 days per week
Reporting Line: R&D Quality Director Health
About the Role:
We are seeking a highly skilled and dedicated Qualified Person (QP) for Investigational Medicinal Products (IMPs). This role is crucial for ensuring compliance with various EU and UK regulations, including Directive 2001/83/EC and SI 2012 no. 1916. The successful candidate will be responsible for the GMP certification of IMPs, ensuring that all operations comply with regulatory requirements.
Key Responsibilities:
- Regulatory Compliance: Ensure compliance with relevant legislation and guidance impacting IMP manufacturing for clinical trials.
- GMP Certification: Certify IMPs manufactured, ensuring all operations meet regulatory standards.
- Quality Systems: Support the maintenance and implementation of robust Quality Systems to facilitate product release.
- Deviation Management: Document deviations, conduct investigations, and implement corrective and preventive actions (CAPAs).
- Training: Provide training and guidance to trainee QPs and other colleagues as needed.
- Documentation Review: Review Clinical Trials Authorisations and manufacturing documentation for QP batch certification.
- Investigation: Involve in the investigation and reporting of suspect/defective medicinal products and medical devices.
Qualifications:
- Qualified Person Status: Must be qualified according to article 49 of EU directive 2001/83/EC and schedule 7 of SI 2012 no. 1916.
- Experience: Demonstrable experience with solid and liquid dosage forms, including knowledge of manufacturing processes, supply chains, and quality control tests.
- Professional Development: Meet the requirements for continuing professional development to maintain QP status.
Why Join Us?
- Impactful Work: Play a key role in ensuring the safety and efficacy of investigational medicinal products.
- Professional Growth: Opportunities for continuous learning and professional development.
- Collaborative Environment: Work with a diverse team of professionals dedicated to making a difference in the health sector.
If you are a qualified and experienced QP looking for a challenging and rewarding opportunity, we would love to hear from you. Apply now to join our team and contribute to the advancement of clinical trials and medicinal product safety.