Chargé de Validation Analytique - Lyon, France - Axplora

Axplora

Entreprise vérifiée

Lyon, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

Axplora's mission is to be a trusted manufacturing partner to the world's leading pharmaceutical and biotechnology companies.

Driven by passion, curiosity, and dedication of our highly skilled employees, we aim to make them being proud to collaborate with our customers to deliver cutting-edge products for the benefit of humankind.

While accomplishing our vision of providing API for medicines on time and at scale, we offer a caring and safe environment in which our people can leverage their full potential.

Our 2.500 employees are based in Europe, India and the USA, and Axplora is organized in 3 BUs (CDMO services, Specialty products, Steroids & HPAPI products).

BU CDMO is gathering more than 1000 employees based in 7 sites located in Europe and USA. It is a leading player in fast-growing CDMO market (ADC, Omega3 ) with technology-driven differentiation such as chromatography, hazardous chemistry, cryogeny and flow chemistry

The industrial site of Chasse sur Rhône (20 min south of Lyon - served by train - 280 employees), is classified SEVESO 3 upper threshold and specializes in the development and custom production of active pharmaceutical ingredients.

Reporting to the Method and Project Manager, your main mission is to organize the analytical development/validation activity and analytical support for new projects.

Your main responsibilities will include:

Reporting to the Methods and Projects Division Manager, your main mission will be to validate and/or transfer analytical methods and analyze products under development in compliance with the Good Manufacturing Practices guide and safety rules.

Your tasks:

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.
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).
Write or correct analytical files. Selfverify its analytical data.

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).

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.

This position is daytime. Technical English desired.