Head of Quality Assurance - SUANFARMA Italia S.p.A.
SUANFARMA is looking for a Head of Quality Assurance to join our team in Rovereto (TN), Italy.
The Head of Quality Assurance, as part of the site's Quality Unit, shall ensure that all quality systems comply with Suanfarma and International guidelines, that regulatory documentation is updated and that all GxP-impacting IT systems with impact on GxP are properly used and validated.
Key Responsibilities
* Lead and coordinate all the activities of the Quality Assurance and Regulatory Team.
* Review batch records.
* Review and approve process and product-related processes and products.
* Manage changes in collaboration with Regulatory Affairs.
* Issue the Site Validation Master Plan.
* Issue the Annual Product Review.
* Issue the Quality Plan and Quality Report.
* Support other functions on quality topics.
* Arrange and plan the annual GMP training courses.
* Arrange and execute suppliers external audits for the Site and for the Company.
* Arrange and execute internal audits.
* Support the preparation of audits by external regulatory bodies with close collaboration with the Audit Coordinator.
* Manage the Quality agreements with suppliers.
* Manage documentation, change control, deviations, complaints and CAPAs together with the QA team.
* Issue regulatory documentation in order to ensure regulatory compliance.
* Support and actively collaborate for achievement of Company projects and tasks.
Reports to: Head of Quality Unit
Profile and Qualifications
* Min. 5 years experience in a similar role or in a senior role in Quality Assurance in a pharmaceutical company.
* Master's degree in Computer Science, Chemical Engineering, Chemistry, Pharmacy or equivalent.
* Fluency in Italian and English.
* Deep knowledge of cGMPs, Regulatory guidelines, Annex 11, Annex 15 and Code of Federal Regulations, Computerized Systems Validation, Project management, Vendor audits and Change control.
* Strong interpersonal, project management, change management, problem-solving and analytical skills.
* Preferred: Qualified person qualification and SAP proficiency.
Location and Travel
This position is based in Rovereto (TN), Italy.
Occasional travels (up to 10% of working time).
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
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