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2 giorni fa
As a Senior Quality Control Specialist - Analytical Documentation at Thermo Fisher Scientific, you will play a crucial role in ensuring the successful continuation of projects within the Pharmaceutical Development Services (PDS) department. Your primary responsibility will be to collaborate with various functions within the company to implement analytical requirements while adhering to quality standards.
Key Responsibilities- Collaborate with clients, QC PDS, regulatory departments, and other stakeholders to issue accurate documents for PDS projects, aligning with ICH and Pharmacopoeia guidelines.
- Develop and maintain comprehensive analytical documentation for APIs, excipients, and DP (release and stability tests), including preparing analytical methods and supporting their upload onto computerized systems.
- Contribute to discussions on compliance consulting and strategic advice for internal and external clients, determining the most suitable approach for compliant documentation.
- Participate in project-specific strategy development, providing technical expertise in QC documentation matters and overseeing collaboration efforts for key client projects.
- Maintain strong communication with key clients, attending regulatory authority meetings, and representing the company in public relations functions.
- Bachelor's degree in chemical engineering, chemistry, or an equivalent field.
- Extensive experience in laboratory analysis, preferably in a pharmaceutical company or university setting.
- In-depth knowledge of GMP standards applied to quality control laboratories, particularly in stability studies.
- Familiarity with data management and evaluation systems.
- A competitive salary of $80,000 per annum, reflecting your skills and experience.
- The opportunity to work with a global organization that values innovation and performance.
- A collaborative and dynamic work environment with opportunities for growth and development.
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