QA Inspection Readiness Lead
il y a 2 semaines
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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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