Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Are you prepared to become a part of a team that is remarkably committed to enable our customers to make the world healthier, cleaner and safer? Our Monza location is in search of a QA Project Specialist for PDS Business Unit to help uphold our top-tier benchmarks and ambitious objectives Specific Tasks/Primary Activities: Batch Release Control: Support the QP and Quality Operations Manager in releasing product batches by verifying analysis certificates and ensuring compliance with specifications. Accurately archive all documentation related to batch records following company procedures. Investigation Record Review: Conduct initial assessments of deviation events and complaints, establishing initial importance and evaluating the necessity for addressing a blocking issue. Review investigation plans and support investigators in identifying root causes and implementing corrective and preventive actions. Customer Management and Inspections: Participate in periodic meetings with customers and provide quality-related support via email. Inform customers of deviation events and complaints, ensuring closure of records in Trackwise. Draft critical metrics for customers and engage in on-site customer visits. Actively participate in audit preparation and support audit presentations. Compliance: Complete assigned training and ensure continuous SOP updates in line with GMP requirements. Review MBRs, change controls, protocols, and reports for clinical and commercial batches. Draft PSFs for clinical batches and continuously update them. Issue Risk Assessments and review FMEAs for PDS projects. Relationships: Internal: Production QA Compliance and Regulatory/QC Business Manager and PMO Technical Services Logistics External: Customers Regulatory Authorities Requirements and Qualifications: Degree in CTF, Pharmacy, Chemistry, Biology, Biotechnology, or a similar scientific field. At least 2 years of experience in the pharmaceutical field. Proficiency in GMP/FDA standards. Proficiency in Italian and English. Personality Traits: Proven teamwork ability. Outstanding time management and problem-solving skills. Excellent relational skills. Join us and contribute to our mission of enabling our customers to make the world healthier, cleaner, and safer J-18808-Ljbffr