Qualification & Validation Coordinator – Life Sciences

Job description

Description du poste

As a Validation and Qualification Consultant, your skills will support the projects of our partners involved in the production of pharmaceuticals or health-related products. You will play a central role in coordinating and executing the validation cycle to successfully complete projects within specified timelines. To achieve this, you will:

 

– Represent the Validation department in various projects.

– Design and implement the best validation strategy.

– Coordinate project planning with all stakeholders (production / QA / maintenance).

– Participate in risk assessment through the preparation of a « Risk assessment. »

– Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS).

– Write protocols, coordinate and ensure the smooth conduct of tests (URS / FAT / SAT / IQ / OQ / PQ).

– Analyze and interpret results to write resulting reports.

– Develop training programs and coach operators in the field.

– Manage deviations related to validation runs and implement associated CAPAs.

Qualifications

You are:

– Curious to learn more about production equipment and/or manufacturing processes.

– Organized and meticulous in the preparation of your GMP documents.

– Communicative and enjoy interactions with different departments such as Production, Quality Assurance, and Maintenance.

Informations supplémentaires

Engineering culture and passion for technology, high value-added projects, mobility offers and personalized career follow-up, it is in an innovative and stimulating environment that our teams mobilize to:  

· 
Innovate: become an actor of the digital transformation by taking part in innovative technological projects within a technological environment based on creativity, innovation and the search for solutions.   

· 
 Evolve: ALTEN is a career gas pedal that allows you to grow quickly and according to your desires. Benefit from dedicated support, with the possibility of training and certification, to develop your expertise and grow within our four areas: Specialists, Project Management, Business Management and Support Functions.  

· 
 Grow: work in an agile group that values the talents of each individual and join a company that is committed: ALTEN develops and finances citizen and solidarity partnerships and offers its employees the opportunity to get involved in these projects.