Senior Qualified Person: Batch Release & Compliance

Catalent Pharma Solutions; Swindon; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Site performance bonus

Pension scheme 8% match

Life assurance

Generous holiday entitlement

LinkedIn Learning access

On-site canteen

Job summary

Catalent is seeking a Qualified Person to lead batch release at our Swindon site, ensuring compliance with UK/EU GMP and internal standards. The role involves reviewing batch records, supporting investigations and CAPA, and coordinating across QA, QC, Operations and Engineering.

You will certify releases, support audits, and drive continuous improvement while keeping up-to-date with regulatory requirements. This is an on-site, standard daytime shift in Swindon, UK.

Qualifications

• Qualified Person status under UK legislation.
• Degree in a Life Science discipline.
• Extensive GMP pharmaceutical manufacturing experience.
• Expertise in batch certification and regulatory compliance.
• Strong knowledge of UK/EU GMP, ICH, and MHRA requirements.
• Experience in investigations, root cause analysis and CAPA.
• Track record supporting audits and regulatory inspections.
• Reviewing technical documentation, validation and change controls.
• Strong analytical and quality decision-making abilities.
• Experience with electronic quality systems.

Responsibilities

• 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 specifications and procedures.
• Oversee deviations, complaints, investigations, CAPA and quality events with effective resolution.
• Review and approve GMP documents, SOPs, validation protocols, change controls, and PQRs.
• Support internal and external audits, supplier qualification, and regulatory inspections.
• Provide quality leadership across QA, QC, Operations, Supply Chain, Engineering, and cross-functional teams.
• Support new product introductions, technology transfers, process changes and continuous improvement.
• Make final risk-based decisions on batch release, rejection or rework, maintaining oversight of critical activities.
• Maintain visibility within operations and stay current with regulatory developments.

Skills

Quality leadership

Cross-functional collaboration

Regulatory compliance

Investigations & CAPA

Audits & inspections

Documentation review

Analytical decision-making

Education

Qualified Person status (UK)

Degree in Life Science

Job description

Catalent is seeking a Qualified Person to lead batch release at our Swindon site, ensuring compliance with UK/EU GMP and internal standards. The role involves reviewing batch records, supporting investigations and CAPA, and coordinating across QA, QC, Operations and Engineering.

You will certify releases, support audits, and drive continuous improvement while keeping up-to-date with regulatory requirements. This is an on-site, standard daytime shift in Swindon, UK.