Ph3Head of Quality Assurance - SUANFARMA Italia S.p.A. /h3 pSUANFARMA is looking for a bHead of Quality Assurance /b to join our team in Rovereto (TN), Italy. /p pThe 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. /p h3Key Responsibilities /h3 ul liLead and coordinate all the activities of the Quality Assurance and Regulatory Team. /li liReview batch records. /li liReview and approve process and product-related processes and products. /li liManage changes in collaboration with Regulatory Affairs. /li liIssue the Site Validation Master Plan. /li liIssue the Annual Product Review. /li liIssue the Quality Plan and Quality Report. /li liSupport other functions on quality topics. /li liArrange and plan the annual GMP training courses. /li liArrange and execute suppliers external audits for the Site and for the Company. /li liArrange and execute internal audits. /li liSupport the preparation of audits by external regulatory bodies with close collaboration with the Audit Coordinator. /li liManage the Quality agreements with suppliers. /li liManage documentation, change control, deviations, complaints and CAPAs together with the QA team. /li liIssue regulatory documentation in order to ensure regulatory compliance. /li liSupport and actively collaborate for achievement of Company projects and tasks. /li /ul pReports to: Head of Quality Unit /p h3Profile and Qualifications /h3 ul liMin. 5 years experience in a similar role or in a senior role in Quality Assurance in a pharmaceutical company. /li liMaster's degree in Computer Science, Chemical Engineering, Chemistry, Pharmacy or equivalent. /li liFluency in Italian and English. /li liDeep knowledge of cGMPs, Regulatory guidelines, Annex 11, Annex 15 and Code of Federal Regulations, Computerized Systems Validation, Project management, Vendor audits and Change control. /li liStrong interpersonal, project management, change management, problem-solving and analytical skills. /li liPreferred: Qualified person qualification and SAP proficiency. /li /ul h3Location and Travel /h3 pThis position is based in Rovereto (TN), Italy. /p pOccasional travels (up to 10% of working time). /p pSeniority level: Director /p pEmployment type: Full-time /p pJob function: Quality Assurance /p /p #J-18808-Ljbffr