Qa Deviations

: Review Master Batch Records, perform Batch Record Review and generate supporting documentation for batch releaseReview and manage deviations, investigations and complaints, in collaborations with all relevant functionsSupport the organization of technical and managerial meetings with clients and participate in customer visits and audits by customers and/or regulatory authorities.Contribute to achieving "zero past due" objectives in Quality (CAPA, Complaints, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTD (On-Time Delivery) objectives for document submission to the client and lot release.Provide quality support to customers by responding to inquiries.Conduct training for personnel involved in Quality activities for PDS.How will you get there?Required Skills and Experience:Degree in Chemistry/ CTF/ Biological Sciences or similar fieldsMulti-year experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturingExcellent knowledge of GMP and national/international regulationsAbility to write, handle and review GMP documentation (Quality Agreement, CAPA…) and understanding of main quality indicators such as RFT (Right First Time) and OTD (On-Time Delivery).Good problem-solving abilities, excellent communication and team working skills and ability to prioritize under time constraints Italian and English