PDS QA Project Specialist

Thermo Fisher Scientific Inc.; Monza; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

Join a leading company in the pharmaceutical industry as a QA Project Specialist in Monza. This role involves ensuring quality compliance, participating in customer management, and collaborating with regulatory authorities. Applicants should have a degree in a scientific field and a minimum of 2 years of experience, alongside skills in GMP and problem-solving.

Competenze

• At least 2 years of experience in the pharmaceutical field.
• Proficiency in GMP / FDA standards.
• Fluent in Italian and English.

Mansioni

• Support Quality Operations in releasing product batches by verifying analysis certificates.
• Conduct initial assessments of deviation events and complaints.
• Participate in audit preparation and support audit presentations.

Conoscenze

Teamwork

Time Management

Problem-Solving

Proficiency in GMP / FDA standards

Proficiency in Italian

Proficiency in English

Formazione

Degree in Pharmacy, Chemistry, Biology, Biotechnology, or a similar field

Descrizione del lavoro

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 in search of a QA Project Specialist for the 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.
• 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 onsite 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 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!

Additional Details :

• Employment Type: Full-Time
• Vacancy: 1
• Experience: Unclear seniority
• Key Skills: Invoicing, IT Support, Database Administration, etc.