Description
A global pharmaceutical organisation require a QC Validation Specialist (French speaking) to develop, validate and transfer analytical methods so that all manufactured products continuously comply with up-to-date regulatory requirements and are considered ``state-of-the art`` methods.Responsibilities to include:
* Develop, validate and transfer analytical methods so that all manufactured products continuously comply with up-to-date regulatory requirements and are considered ``state-of-the art`` methods, in accordance to Corporate Quality Module 7.1.
* Update Plant products analytical method gap analysis on an on-going basis to ensure analytical method development and validation status is updated and comply to the Plant Validation Master Plan
* Work with the selected external third-party & Internal QC laboratories to develop, validate and transfer methods as per agreed project timelines and business needs.
* Update KPI to monitor vendor performance. Monitor KPI and take follow-up actions accordingly.
* Write associated CMC analytical documents to support product registration.
Minimum requirements:
* Chemist with a significant experience in Quality Control
* Thorough knowledge of requirements and QC
* QC & Regulatory expertise in Pharmaceutical industry
* Analytical method validation and analytical equipment (HPLC / GC etc) validation
* French: Fluent (oral & written) / English: Fluent (oral & written)
This is a brilliant long term contract opportunity working in a dynamic environment offering competitive rates of pay. Please apply now for more information.