**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office 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**: - 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!

📌 Pds QA Project Specialist (Monza)
🏢 Thermo Fisher Scientific
📍 Monza