Analytical Development Specialist
4 ore fa
We are seeking a highly skilled Quality Control Documentation Expert to join our team at Thermo Fisher Scientific. As a key member of our PDS Analytical Development & GMP Department, you will be responsible for ensuring the successful continuation of projects within the Pharmaceutical Department.
Key Responsibilities- Document Control: Responsible for the analytical documentation of APIs, Excipients, and DP (release and stability tests), ensuring compliance with ICH and Pharmacopoeia standards.
- Collaboration: Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA, and QO to issue correct documents for PDS projects.
- Compliance Consulting: Provide compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach for compliant documentation.
- Project Management: Provide project-specific strategy, technical expertise in QC Documentation matters, and coordination oversight for key client projects.
- Executive Contact: Serve as the executive contact for key clients, ensuring quality performance for managed projects.
- Root Cause Analysis: Responsible for the evaluation of OOS, OOT, and laboratory investigations in terms of recurrences, root cause, trend, and define CAPAs.
- Education: Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies.
- Skills: GMP standards applied to Quality Control laboratories, with particular reference to stability studies, laboratory data management, and SOP writing.
- Language: English and Italian proficiency.
- Soft Skills: Flexibility, adaptability, good organization and planning skills, excellent listening, oral, and written communication skills, and ability to work in a team.
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PDS Analytical Development Specialist
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a highly skilled and experienced PDS Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Services (PDS) team, you will play a critical role in supporting the development of new pharmaceutical products.Key ResponsibilitiesCoordinate and plan laboratory...
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