Overview
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.
Provide training on quality topics.
Responsibilities
1. 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.
2. Participate in the writing, reviewing, approval of QMS documents: QM, POL, SOP, WKI, FORM.
3. Lead the Quality Management Review : coordinate the reviews, provide the inputs and manage the follow-up actions.
4. Drive and maintain an appropriate level of compliance to Mithra CDMO QMS.
5. Perform quality KPIs follow-up and provide active support to keep them within specifications.
6. Ensure the management of deviation, CAPA, CC within the area of expertise.
7. Ensure that critical topics are adequately and timely escalated to higher QA management
8. Provide training on quality topics
9. Actively participate in continuous improvement of activities
10. 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:
11. Pharmaceutical regulations / GMP (EU and US)
12. QA
13. Inspection readiness
14. Inspection/audit management
15. Change Management
16. Fluent French and English
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