V.I.E. Qualification & Validation Coordinator M/F – Life Science

Job description

Description du poste

As a Qualification and Validation consultant, your skills will support the projects of our partners whose activities are established in the production of medicines or health-related products.
You will play a central role in coordinating and executing the validation cycle with the aim of finalising projects successfully and on time. To do this, you will:
Represent the Validation department on the various projects;
Design and implement the best Validation strategy;
Coordinate project planning with all stakeholders (production / QA / maintenance);
Participate in risk assessment by drafting a risk assessment;
Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS);
Write protocols, coordinate and ensure the smooth running of tests (URS / FAT / SAT / IQ / OQ / PQ);
Analyse and interpret the results and write the resulting reports;
Develop training courses and coach operators in the field;
Manage deviations linked to validation runs and implement the associated CAPAs.

Qualifications

You are : Curious to learn more about production equipment and/or manufacturing processes;
Organised and rigorous in the drafting of your GMP documents;
Communicative and enjoy interacting with different departments such as: Production / Quality Assurance / Maintenance.

You have : A degree in Engineering, a Masters in Bio-Engineering, Industrial Pharmacy or related fields;
Experience in qualification and validation in a GMP environment;
Knowledge of production processes in the pharmaceutical industry;
Ability to work in English as well as French.

Informations supplémentaires