Qualified Person (QP)

Swindon Source: WhatJobs
See advert for pay

Overview

In this role you will certify and release batches in line with UK/EU regulations to safeguard product quality. You will lead quality decisions and collaborate across QA, QC, Operations and other functions to ensure compliance and robust documentation. You will support audits, investigations and continuous improvement to drive excellence at the Swindon site. This is a hands-on leadership position with visibility across the organization and a focus on regulatory readiness and risk-based decision making. You will contribute to shaping quality culture and site performance within Catalent’s global network.

Pay / Benefits

  • site performance bonus
  • pension scheme matching up to 8%
  • life assurance
  • generous holiday entitlement
  • LinkedIn Learning access
  • Cycle to Work Scheme

Responsibilities

  • Certify and release batches per UK/EU GMP and internal standards
  • Review and approve batch records, analytical data, and disposition documentation
  • Oversee deviations, investigations, CAPAs, and quality events with effective resolution
  • Review and approve GMP documentation, validation protocols, change controls, and Product Quality Reviews
  • Support internal/external audits, supplier qualification, and regulatory inspections
  • Provide quality leadership across QA, QC, Operations, Supply Chain, and Engineering
  • Support new product introductions, technology transfers, process changes, and continuous improvement
  • Make final risk-based release, rejection, or rework decisions with oversight of critical quality activities

Key requirements

  • Qualified Person status under UK legislation
  • Degree in Life Science
  • Extensive GMP pharmaceutical manufacturing experience
  • Expertise in batch certification and regulatory compliance
  • Knowledge of UK/EU GMP, ICH, MHRA requirements
  • Experience in investigations, root cause analysis, and CAPA
  • Track record supporting audits and regulatory inspections
  • Experience reviewing technical documentation, validation, and change controls
  • Strong analytical and quality decision-making skills
  • Effective cross-functional collaboration and experience with electronic quality systems
  • Leadership experience (Catalent programs may substitute external experience)
  • exceptional communicator
  • influencing stakeholders at all levels
  • sound judgement and integrity
  • GMP/compliance knowledge
  • batch certification and release
  • batch records and analytical data review

Full job description from WhatJobs. Apply for this role →

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