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Quality R&D Operations Specialist – 2-Year Contract

GSK · Wavre

Hybrid 🇬🇧 English
GMP CAPA Change control Technical investigations Qualification and validation Root cause analysis Inspection readiness Electronic quality management systems Electronic batch records SAP

Job description

About the role

You will support operational quality assurance across our Belgium R&D site, working with analytical R&D labs and GMP clinical manufacturing operations for drug substance, aseptic drug product, or technical services. The role provides practical coaching, hands‑on experience and clear development paths within a collaborative team.

Key responsibilities

  • Provide day‑to‑day QA oversight for R&D operations related to clinical manufacturing and testing to ensure GMP and GSK quality standards.
  • Review and approve deviations, change controls, CAPA and technical records promptly.
  • Review and approve qualification and validation activities for processes or equipment.
  • Lead or support investigations and root‑cause analysis for quality events and implement corrective actions.
  • Conduct self‑inspections, support external inspections and drive inspection readiness.
  • Monitor quality metrics, perform trend analysis and work with teams on continuous improvement.
  • Coach and advise cross‑functional teams on quality expectations, data integrity and documentation best practices.

Required profile

  • Degree in life sciences, pharmacy, engineering, chemistry or equivalent practical experience.
  • Experience in a regulated pharmaceutical, biotech or related R&D/manufacturing environment.
  • Practical knowledge of Good Manufacturing Practice (GMP).
  • Experience handling deviations, CAPA, change control and technical investigations.
  • Strong written and spoken English; French or Dutch knowledge is an advantage.
  • Ability to work on‑site in Belgium and occasional shifts; fluency in French is a plus.

Required skills

  • GMP knowledge
  • Deviation management
  • CAPA handling
  • Change control
  • Technical investigations
  • Qualification & validation activities
  • Root‑cause analysis
  • Inspection readiness
  • Quality metrics monitoring & trend analysis
  • Electronic quality management systems (eQMS)
  • Electronic batch records
  • SAP

What we offer

  • 2‑year fixed‑term contract
  • Practical coaching and hands‑on experience
  • Clear development paths and career growth
  • Visible impact on R&D quality
  • Collaborative team environment
  • Occasional hybrid working as agreed

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Published 3 months ago

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GSK

Wavre