Qualified Person (QP)

Catalent, Inc; Swindon; Sur place; GBP 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Site performance bonus

Pension scheme up to 8%

Life assurance

Generous holiday entitlement

Cycle to Work Scheme

Electric Vehicle car scheme

LinkedIn Learning subscription

Résumé du poste

Catalent, Inc. in Swindon is seeking a Qualified Person to certify and release batches in line with UK/EU regulations and internal standards. You will lead cross-functional teams to maintain high quality and regulatory compliance across the site.

You will review batch records, support investigations, CAPAs, and continuous improvement initiatives while ensuring timely product disposition. Strong ICP leadership and audit experience are essential for success.

Qualifications

• Qualified Person status under UK legislation.
• Degree in Life Science or equivalent.
• Extensive GMP pharmaceutical manufacturing experience.
• Expertise in batch certification and regulatory compliance.
• Experience supporting audits and regulatory inspections.
• Strong analytical and quality decision-making skills.

Responsabilités

• Certify and release batches in compliance with UK/EU regulations and internal standards.
• Review and approve batch records, analytical data, and supporting documentation for product disposition.
• Ensure products are manufactured, tested, and validated per specs and procedures.
• Oversee deviations, investigations, CAPAs, and quality events with effective resolutions.
• Review and approve GMP documentation including SOPs, validation protocols, change controls, and PQRs.
• Support audits, supplier qualification activities, and regulatory inspections.
• Provide quality leadership across QA, QC, Operations, Supply Chain, and Engineering.
• Support new product introductions, tech transfers, and process changes.
• Make final risk-based decisions on batch release, rejection, or rework.

Connaissances

Analytical skills

Quality decision-making

Cross-functional collaboration

Leadership experience

Communication skills

Problem solving

Shop-floor engagement

Formation

Degree in Life Science

Qualified Person status under UK legislation

Electronic quality systems

Outils

Electronic quality systems

Description du poste

We have an opportunity for a Qualified Person to join our team and play a key role in ensuring product quality and compliance. You will be responsible for certifying and releasing batches in line with UK/EU regulations and internal standards. This position involves close collaboration across multiple departments to maintain the highest levels of quality and regulatory compliance. You will also support audits, investigations, and continuous improvement initiatives while providing quality leadership across the site.,

• Certify and release batches in compliance with UK/EU regulations, Good Manufacturing Practice, and internal quality standards.
• Review and approve batch records, analytical data, and supporting documentation to support product disposition.
• Ensure products are manufactured, tested, and validated in line with approved specifications and procedures.
• Oversee deviations, complaints, investigations, Corrective and Preventive Actions, and quality events, ensuring effective resolution and compliance.
• Review and approve Good Manufacturing Practice documentation, including Standard Operating Procedures, validation protocols, change controls, and Product Quality Reviews.
• Support internal and external audits, supplier qualification activities, and regulatory inspections.
• Provide quality leadership across Quality Assurance, Quality Control, Operations, Supply Chain, Engineering, and other cross-functional teams.
• Support new product introductions, technology transfers, process changes, and continuous improvement initiatives.
• Make final risk-based decisions on batch release, rejection, or rework, maintaining oversight of quality-critical activities.
• Maintain visibility within operations, stay current with regulatory developments, and undertake additional duties as required by the business.
  Qualified Person status under UK legislation.
• Degree in a relevant Life Science discipline.
• Extensive Good Manufacturing Practice pharmaceutical manufacturing experience.
• Expertise in batch certification and regulatory compliance.
• Strong knowledge of UK/EU Good Manufacturing Practice, International Council for Harmonisation, and Medicines and Healthcare products Regulatory Agency requirements.
• Proven experience in investigations, root cause analysis, and Corrective and Preventive Actions.
• Track record supporting audits and regulatory inspections.
• Skilled in reviewing technical documentation, validation, and change controls.
• Strong analytical and quality decision-making skills.
• Effective cross-functional collaboration and experience with electronic quality systems.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

• Respected leader with the confidence to act as the independent quality authority.
• Exceptional communicator, able to influence stakeholders at all levels.
• Sound judgement and integrity, with a strong risk-based approach to decision making.
• Passion for coaching and developing teams while promoting quality ownership.
• Calm and decisive when managing quality issues and critical release decisions.
• Highly organised, with the ability to balance multiple priorities and deadlines.
• Collaborative mindset that builds strong relationships across functions and sites.
• Commitment to continuous learning and industry best practice.
• Hands-on approach with strong shop-floor engagement and operational focus.
  Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
  Competitive Salary - Reflecting your experience and skills.
• Bonus & Benefits - Includes a site performance bonus, a pension scheme matching up to 8% and life assurance. Enjoy a generous holiday entitlement that increases with tenure, with the option to purchase additional leave. Plus, gain access to Reward Gateway, offering discounts at many national retailers.
• Career Development - Access high-quality training, mentoring, and cross-functional opportunities within Catalent's global network. Benefit from a subscription to LinkedIn Learning, providing access to 10,000+ online courses.
• Health & Wellbeing - Includes an employee assistance programme, on-site canteen facilities, and an active safety and "Patient First" culture. Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme.
• Excellent Location - Just a two-minute drive from J16 of the M4, with free on-site parking.