Qualified Person; QP

Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.

Continued growth and investment into the business has led to the creation of exciting new job opportunities in our new GMP Manufacturing headquarters in Beeston, Nottingham. Upperton Pharma Solutions is undergoing a period of significant expansion to meet international customer demand and offer a comprehensive drug development portfolio, so now is a great time to join our team.

The Qualified Person (QP) is legal responsibility under UK and EU law, including EU Directives 2001/83, 2001/20 and 2003/94, and namely ensuring that each batch of medicinal product has been manufactured and checked in compliance with UK/EU GMP in accordance with CTA, PSF and IMPD.

• Complete batch dispositions decisions as required and ensure that the appropriate systems are in place to support batch disposition
• Support the site in developing policies and procedures to comply with GMP
• Ensure the site team have an up to date and appropriate level of GMP knowledge
• Bring to the attention of senior management any GMP non-compliance or concerns about future non-compliances
• Ensuring that the appropriate systems are in place for final batch disposition
• Supporting the company in client interactions as required
• Providing GMP expertise in problem solving and change management
• Supporting regulatory inspections and customer audits
• Provide technical support to the site team in matters of regulatory compliance and product safety
• Complete site training as required to ensure appropriate GMP system maintenance and site regulatory knowledge.
• Assess site compliance through customer audit and appropriate management review
• Support the site in obtaining competent authority registrations
• Monitor product quality as needed through tracking and trending of site quality indicators
• Conduct investigations and reports as required

• Eligibility to act as a UK Qualified Person, recognised by the Joint professional bodies:
• Eligible to be named on a UK Manufacturing and Importation Authorisation (MA)
• Full understanding of the legal responsibilities of UK QP and commitment to compliance with the QP Code of Practice
• Significant experience working within UK GMP-licensed pharmaceutical manufacturing
• Strong practical experience with:
• Batch certificates and release decision making
• Deviation and OOS management
• Root cause analysis and CAPA
• Change control and quality risk management
• Strong communication skills with the ability to challenge constructively at all organisational levels
• High integrity and confidence to make independent, defensible quality decisions
• Ability to work calmly and decisively under pressure and tight timelines

We offer employees not only a competitive salary but also an excellent suite of benefits including:

• 30 days holiday and your birthday off!
• Company contributory pension package
• Life insurance
• Private Medical Insurance through Vitality
• Free onsite car parking
• Modern offices located just 2 minutes from Beeston train station

We know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fundraising events.

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