Analytical Development and Validation Specialist

il y a 3 jours


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

Job Summary

We are seeking an Analytical Development and Validation Specialist to join our team at Axplora. As a key member of our Methods and Projects Division, you will be responsible for organizing the analytical development/validation activity and analytical support for new projects.

Main Responsibilities

Validate and/or transfer analytical methods and analyze products under development in compliance with the Good Manufacturing Practices guide and safety rules.

Key Tasks

1. Validate or transfer analytical methods:

Write validation and/or transfer protocols for raw materials, work in progress or finished products,

Coordinate the execution of tests,

Process the results and write the validation report,

Ensure the management of deviations and analytical investigations,

Check validation protocols and reports and/or analytical transfers.

2. Apply the necessary Quality rules (Good Manufacturing Practices, etc.):

Participate in the training of analysts in the various analytical techniques,

Carry out 1st level maintenance tasks for laboratory equipment,

Participate in the implementation of improvements in the functioning of the laboratory (eg: implementation of procedures).

Qualifications

You hold a Bac +5 in analytical chemistry, or BAC +3 with significant experience in a control laboratory in validation and/or analytical transfers. You ideally have solid knowledge of analytical chemistry with particular knowledge of chromatographic techniques (HPLC / UPLC / GC / GC-HS).

Requirements

Involved, curious, and proactive, you have a spirit of synthesis that allows you to have a sense of priorities in your daily work in compliance with HSE and quality rules (BPF). You are autonomous, rigorous and have a sense of organization. With a team spirit, you demonstrate flexibility and adaptability.



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