PDS QA Project Specialist

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!