V.I.E. Qualification & Validation Coordinator – Life Science
- Temps complet
- Contract Type: VIE
Description de l'entreprise
ALTEN Belgium is a leading consulting company in the fields of engineering, life sciences and IT in which consultants are at the centre.
Why join us?
Since its creation in 2016, ALTEN Belgium's Life Sciences division has continued to grow and today occupies a leading position in the Life Sciences and Biotechnology market in Belgium. Joining ALTEN Belgium's Life Sciences division and its 300 consultants also gives you the opportunity to continually acquire new expertise to boost your career. How can we do this? By allowing you to work within large and small structures on the most stimulating and challenging projects on the market!
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.