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Analytical Validation Specialist

Il y a 2 mois


ChassesurRhône, Auvergne-Rhône-Alpes, France Novasep Temps plein

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:

  1. Develop and execute validation protocols for analytical methods, ensuring compliance with GMP standards.
  2. Coordinate the execution of analytical tests and process the results to generate comprehensive validation reports.
  3. Manage deviations and conduct thorough investigations to ensure data integrity and method robustness.
  4. Review and approve validation protocols and reports, ensuring accuracy and completeness.
  5. Provide training to analysts on various analytical techniques and laboratory procedures.
  6. Perform routine maintenance tasks for laboratory equipment to ensure optimal performance.
  7. 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.