QA Inspection Readiness Lead

il y a 2 semaines


Liège, Wallonie, Belgique TN Belgium Temps plein

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Responsibilities

  • Ensure governance of clients' audits and authorities' inspections for Mithra CDMO. Ensure inspection/audit readiness. Actively participate in audits/inspections. Participate in addressing audits/inspections' observations.
  • Participate in the writing, reviewing, approval of QMS documents: quality manual, policies, SOP, working instructions, forms.
  • Lead the Quality Management Review: coordinate the reviews, provide the inputs and manage the follow-up actions.
  • Drive and maintain an appropriate level of compliance to Mithra CDMO QMS.
  • Perform quality KPIs follow-up and provide active support to keep them within specifications.
  • Ensure the management of deviation, CAPA, CC within the area of expertise.
  • Ensure that critical topics are adequately and timely escalated to higher QA management.
  • Provide training on quality topics.
  • Actively participate in continuous improvement of activities.
  • Follow training as needed to fulfill function requirements.

Qualifications

Bachelor in Sciences.

Minimum 8 years as QA Compliance Expert in Pharmaceutical Company with experience in audit and inspection.

Knowledge:

  • Pharmaceutical regulations / GMP (EU and US)
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