Summary
Performs preparation and management of external and corporate audits and Health Authority inspections.
About the Role
Major accountabilities:
- Act as a Program/Project Manager for the Quality Stream linked to main projects at site level.
- Act as CAPA Plan and Remediation Plan Program/Project Manager ensuring the respect of the timeline, assess and prevent any potential interferences between projects and CAPA/Remediation plans.
- Oversight of all production and testing activities, ensures compliance with cGxP, including data integrity and eCompliance with specific focus on Quality Workstream for the main projects on site.
- Support exception investigations.
- Review and approval of production, QC and AS&T records.
- Support site qualification and validation activities (planning, advising, review).
- Implementation of Quality Systems (incl. documentation management).
- Supplier management activities (agreements, oversight, audit).
Essential requirements:
- Scientific degree.
- Solid previous experience in a QA Compliance department within the pharmaceutical industry.
- Project management skills.
- Fluent in Italian and English.
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