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Analytical Validation Specialist
Il y a 2 mois
About Novasep
Novasep is a global leader in providing innovative solutions for the pharmaceutical and biotechnology industries. With a strong commitment to quality, safety, and sustainability, we partner with our clients to develop and manufacture high-quality products that improve lives worldwide.
About Our CDMO Services
Our Contract Development and Manufacturing Organization (CDMO) division is at the forefront of delivering cutting-edge solutions for complex drug development programs. We specialize in a wide range of technologies, including chromatography, hazardous chemistry, cryogeny, and flow chemistry, enabling us to support our clients throughout the entire product lifecycle.
The Role: Analytical Validation Specialist
Reporting to the Methods and Projects Division Manager, you will play a crucial role in ensuring the quality and reliability of our analytical methods. Your primary responsibility will be to validate and/or transfer analytical methods for raw materials, work-in-progress, and finished products, adhering to Good Manufacturing Practices (GMP) and safety regulations.
Key Responsibilities:
- Develop and execute validation protocols for analytical methods, ensuring compliance with GMP standards.
- Coordinate the execution of analytical tests and process the results to generate comprehensive validation reports.
- Manage deviations and conduct thorough investigations to ensure data integrity and method robustness.
- Review and approve validation protocols and reports, ensuring accuracy and completeness.
- Provide training to analysts on various analytical techniques and laboratory procedures.
- Perform routine maintenance tasks for laboratory equipment to ensure optimal performance.
- Contribute to the implementation of process improvements within the laboratory environment.
Qualifications:
You hold a Bachelor's or Master's degree in Analytical Chemistry or a related field. Proven experience in a control laboratory, specifically in validation and/or analytical transfers, is highly desirable. A strong understanding of analytical chemistry principles, particularly chromatographic techniques (HPLC, UPLC, GC, GC-HS), is essential.
You are a detail-oriented individual with excellent organizational and communication skills. Your proactive approach and ability to work independently and as part of a team will contribute to your success in this role.