Senior Qualified Person – GMP Batch Release Lead

Catalent, Inc; Cheltenham; On-site; GBP 55,000 - 70,000; Full time

Benefits offered by this job

Site performance bonus

Pension scheme matching up to 8%

Life assurance

Generous holiday entitlement

LinkedIn Learning access

Job summary

Catalent, Inc. Swindon site seeks a Qualified Person to certify and release batches in line with UK/EU regulations and internal standards. The role collaborates with QA, QC, Operations and Supply Chain to maintain regulatory compliance and drive continuous improvement.

You will review batch records, analytical data and supporting documentation, ensuring products meet specifications. The role involves audits, investigations and final risk-based release decisions on batches onsite.

Qualifications

• 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 GMP, ICH and MHRA requirements.
• Proven experience in investigations, root cause analysis, and CAPAs.
• Track record supporting audits and regulatory inspections.
• Reviewing technical documentation, validation and change controls.
• Strong analytical and quality decision-making skills.
• Cross-functional collaboration and experience with electronic quality systems.

Responsibilities

• Certify and release batches in compliance with UK/EU regulations, GMP, and internal standards.
• Review and approve batch records, analytical data and supporting documentation.
• Ensure products are manufactured, tested and validated per specifications and procedures.
• Oversee deviations, complaints, investigations, CAPA, and quality events.
• Review and approve GMP documentation including SOPs, validation protocols, change controls and PRs.
• Support audits, supplier qualification activities and regulatory inspections.
• Provide quality leadership across QA, QC, Operations, Supply Chain and Engineering.
• Support NPI, tech transfers, process changes and continuous improvement initiatives.

Skills

QP status

GMP knowledge

Regulatory compliance

Cross-functional leadership

Auditing

Education

Degree in Life Science

Tools

Electronic quality systems

Job description

Catalent, Inc. Swindon site seeks a Qualified Person to certify and release batches in line with UK/EU regulations and internal standards. The role collaborates with QA, QC, Operations and Supply Chain to maintain regulatory compliance and drive continuous improvement.

You will review batch records, analytical data and supporting documentation, ensuring products meet specifications. The role involves audits, investigations and final risk-based release decisions on batches onsite.