Senior QA Specialist 3rd Party

Main accountabilities:
1) Right level of quality
Bring quality expertise, oversight and coordinate change controls, investigations of customer complaints, CAPAs plans. Escalate and alert management in case of issues (risk management in place with contract manufacturers). Monitor performance and continuous improvement actions (KPIs, action plans ).

2) QMS & documentation
Coordinate the implementation of QMS documents related to the qualification, follow up and management of third party.
Follow up CAPA and make sure they are completed in due time. Ensure consistency, availability, and appropriate storage of all applicable quality documentation in C-QMS (Ceva Quality Management System).

3) Community building
Actively participate to the Global Quality and Global External Manufacturing communities, by being part of inspections when needed, and supporting Global Quality in joined Audits.

4) Audit & Inspections
Perform third-party qualification audits & follow up based on appropriate and applicable guidelines,
Prepare & perform audits (audit scheduling, preparation).
Write audits reports and follow CAPA plans.
Be trained in auditing third parties with different guidelines and referentials.

**Your profile**:
Education background - At least Master degree in pharma sciences (Quality Management, Pharmaceutical Engineering, Chemistry or Biotechnology).

Work Experience - Minimum 5 years experience in a pharmaceutical field under EU GMP and FDA regulations, working in a Quality Assurance department ideally.
Pharmaceutical & Biological industry experience, as well as expertise in aseptic processes (as the new Annex 1) are preferred.

Other - Knowledge of French language desired but not required.
Quality Auditor certification preferred.
Experience with Pharmaceutical Quality Management software systems.

Core competencies - Drive ambition, influence others, collaborate with empathy, able to deal with complexity and customer oriented.

Job based ideally in Libourne, international travels required to some affiliates, facilities and third parties (20% of time).