PDS QA Project Specialist

Experteer Italy; Monza; In loco; EUR 30.000 - 60.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a QA Project Specialist to join their dedicated team in Monza. This role is pivotal in ensuring product quality and compliance with GMP/FDA standards while supporting batch release and customer management. The ideal candidate will possess a degree in a scientific field and have a proven track record in the pharmaceutical industry. Join this mission-driven organization and contribute to making the world healthier, cleaner, and safer through your expertise and commitment to quality.

Competenze

• 2+ years of experience in the pharmaceutical field.
• Proficiency in Italian and English.

Mansioni

• Support batch release control and ensure compliance with specifications.
• Conduct assessments of deviation events and support investigations.
• Participate in customer meetings and provide quality-related support.

Conoscenze

GMP/FDA Standards

Problem Solving

Time Management

Teamwork

Customer Management

Formazione

Degree in CTF, Pharmacy, Chemistry, Biology, or Biotechnology

Descrizione del lavoro

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 enabling our customers to make the world healthier, cleaner, and safer? Our Monza location is seeking a QA Project Specialist for the PDS Business Unit to uphold our top-tier benchmarks and ambitious objectives!

Specific Tasks/Primary Activities

1. 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.
2. 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.
3. 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.
4. 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.
5. 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!