PDS QA Project Specialist
PDS QA Project Specialist
Posted on :
23-04-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 toptier 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 qualityrelated 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 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 problemsolving skills.
- Excellent relational skills.
Join us and contribute to our mission of enabling our customers to make the world healthier cleaner and safer!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
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