Qualified Person – Quality Leader (Swindon)

Catalent; Swindon; On-site; GBP 75,000 - 95,000; Full time

Benefits offered by this job

Site bonus

Pension up to 8%

Life assurance

Holiday entitlement growth

LinkedIn Learning access

Employee discounts

Cycle to work

EV car scheme

Job summary

Catalent Swindon site seeks a Qualified Person to certify and release batches in line with UK/EU GMP and internal standards. You will review batch records, analytical data, and supporting docs, ensuring products meet approved specs and procedures while leading quality across multiple functions.

The role involves handling deviations, investigations, CAPAs, and quality events, supporting audits, and contributing to continuous improvement initiatives. Onsite Mon-Fri, Swindon, UK.

Qualifications

• Qualified Person status under UK legislation.
• Degree in 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 and CAPAs.
• Track record supporting audits/regulatory inspections.
• Experience reviewing technical documentation, validation, and change controls.
• Strong analytical and quality decision-making skills.
• Experience with electronic quality systems.

Responsibilities

• Certify and release batches in line with UK/EU regulations 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, CAPAs, and quality events with compliant resolutions.
• Review and approve GMP documentation, SOPs, validation protocols, change controls, and PQRs.
• Support internal and external audits, supplier qualification activities, and regulatory inspections.
• Provide quality leadership across QA, QC, Operations, Supply Chain, Engineering, and cross-functional teams.
• Support new product introductions, tech transfers, process changes, and continuous improvement.
• Make final risk-based decisions on batch release, rejection, or rework, maintaining oversight.

Skills

QP status

GMP experience

Batch release

Regulatory knowledge

Audits

Root cause analysis

Documentation review

Cross-functional collaboration

Leadership programs

Quality decision making

Education

Life Science degree

Job description

Catalent Swindon site seeks a Qualified Person to certify and release batches in line with UK/EU GMP and internal standards. You will review batch records, analytical data, and supporting docs, ensuring products meet approved specs and procedures while leading quality across multiple functions.

The role involves handling deviations, investigations, CAPAs, and quality events, supporting audits, and contributing to continuous improvement initiatives. Onsite Mon-Fri, Swindon, UK.