At a Glance
- Tasks: Ensure compliance and quality in pharmaceutical manufacturing as a Qualified Person.
- Company: Leading pharmaceutical manufacturer with a strong focus on quality.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for global exposure.
- Other info: Collaborative culture with high-impact roles and career growth opportunities.
- Why this job: Play a key role in ensuring product safety and quality in a dynamic industry.
- Qualifications: Eligible QP status and experience in GMP pharmaceutical environments required.
The predicted salary is between 40000 - 50000 £ per year.
A leading pharmaceutical manufacturer is seeking an experienced Qualified Person (QP) to join its Quality function. This is an excellent opportunity to play a key role in ensuring products are certified and released in compliance with UK and EU GMP requirements while supporting both commercial and investigational medicinal products. The successful candidate will provide QP oversight across manufacturing operations, contribute to the Pharmaceutical Quality System, and work closely with cross-functional teams to maintain the highest standards of quality and compliance.
Key Responsibilities
- Act as a Qualified Person in accordance with EU GMP Annex 16 and applicable UK legislation.
- Certify commercial and investigational medicinal product batches for release.
- Ensure batches comply with Marketing Authorisations, Product Specifications, GMP requirements and Quality Technical Agreements.
- Review and approve Annual Product Reviews (APRs) and Product Quality Reviews (PQRs).
- Provide QP support to internal project teams and new product initiatives.
- Participate in customer meetings, technical discussions and project reviews.
- Represent Quality during customer audits, regulatory inspections and client visits.
- Review and approve Quality Technical Agreements with customers and external partners.
- Support the development and continuous improvement of the Pharmaceutical Quality System (PQS).
- Review and approve deviations, CAPAs, change controls, investigations and other key quality documentation.
- Contribute to quality risk management activities and continuous improvement initiatives.
- Participate in internal and external audit programmes.
- Maintain current knowledge of GMP regulations, Annex 16 requirements and industry best practices.
Requirements
- Eligible to act as a Qualified Person (QP) in the UK.
- Previous experience performing QP batch certification within a GMP pharmaceutical manufacturing environment.
- Strong knowledge of EU GMP, Annex 16 and pharmaceutical quality systems.
- Experience supporting commercial and/or investigational medicinal products.
- Proven experience reviewing quality documentation including deviations, CAPAs, change controls and investigations.
- Experience participating in regulatory inspections and customer audits.
- Excellent communication and stakeholder management skills.
- Strong attention to detail with a proactive, risk-based approach to quality.
Desirable Experience
- Experience within a Contract Development and Manufacturing Organisation (CDMO).
- Exposure to both commercial and clinical manufacturing.
- Experience reviewing Quality Technical Agreements.
- Broad understanding of pharmaceutical manufacturing operations and cross-functional quality support.
What's on Offer
- Permanent opportunity with a leading pharmaceutical manufacturer.
- High-impact role within an established Quality organisation.
- Exposure to both commercial and investigational products.
- Collaborative environment with opportunities to support global manufacturing programmes.
- Competitive salary and comprehensive benefits package.
Qualified Person employer: Thor
Join a leading pharmaceutical manufacturer in the Midlands, where you will play a pivotal role as a Qualified Person, ensuring compliance with UK and EU GMP standards. Our collaborative work culture fosters professional growth and offers exposure to both commercial and investigational products, alongside a competitive salary and comprehensive benefits package. This is an excellent opportunity for those seeking meaningful and rewarding employment in a high-impact role within an established Quality organisation.
