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QC Team Lead

msd · IRL - Carlow - Carlow

New
Hybrid 🇬🇧 English
CGMP/GDP compliance Quality Management Systems (QMS)

Job description

About the role

Our Carlow site is a state‑of‑the‑art manufacturing facility for vaccines, biologics and small‑molecule drug products. Reporting to the QC Manager, the QC Team Lead will lead the Sample Management team, drive CGMP/GDP compliance and ensure reliable, safe product supply.

Key responsibilities

  • Lead, mentor and schedule the Sample Management team to meet KPIs.
  • Drive CGMP/GDP compliance and enforce ALCOA+ data‑integrity principles.
  • Escalate any potential GMP violations and support investigations.
  • Provide quality expertise for new product introductions and release activities.
  • Generate performance metrics, quality event reports and support QMS monitoring.
  • Participate in internal and external audits as the auditee for assigned areas.

Required profile

  • Bachelor’s degree in a scientific discipline (or 5+ years relevant experience).
  • Minimum 3 years experience in the pharmaceutical industry.
  • Strong understanding of GMP, data integrity and ALCOA+ principles.
  • Proven leadership and team‑coaching abilities.
  • Effective troubleshooting and continuous‑improvement mindset.

Required skills

  • Data integrity (ALCOA+)
  • CGMP/GDP compliance
  • Quality Management Systems (QMS)
  • Sample management procedures
  • Technical procedures and troubleshooting

Questions fréquentes

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Source : ats:workday

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Published 7 hours ago

Expires 1 month from now

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msd

IRL - Carlow - Carlow