JOBS

Back

QA Release Project Leader(H/F)

February 24th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

Pharmaceutical Quality System
He/she is the Subject Matter Expert covering QA questions related to QA Release project launch activities, by customers or internal teams.

Communication
He/she communicates and interacts effectively with the colleagues of QA department for QA aspects related to projects he/she is leading (e.g. for initial manufacturers/suppliers/subcontractors approval, for equipment management lent by customers, for document review,…).

Planning management
He/she manages the action log related to projects he/she is leading and respects the timelines.

Documentation & release
He/she manages set up and leads change management initiative of project launch specific documents for QA department.
He/she reviews and challenges, in compliance with the IMPD and the current regulations, the Master Batch Record, the Specifications, the procedures, the forms, the instructions and the analytical methods.
Material release, the Drug Product Label, the Environmental Monitoring, the bath records.
Deviations, CAPA’s, Changes Controls and Risk Analysis.

Trends & continuous improvement
He/she implements and follows-up Key Performance Indicators. He/she proposes and takes appropriate actions.

Training & Tech Transfer
He/she manages the QA aspects of technology transfer related to his/her projects.
He/she manages the QA activities related to his/her projects he/she is leading.

 

Candidate profile

OBLIGATORY REQUIREMENTS

At least Graduate level in Sciences.
At least 3-5 years experience in quality assurance is required.
Previous experience in cGMP environment.
Fluency in French and good speaking, reading comprehension and writing skills in English.

USEFUL REQUIREMENTS

Efficient communicator and willing to bring new challenges.
Demonstrated leadership and cross functional team spirit.
Rigorous, conscientious, versatile, open-minded and quality-minded.
Customer oriented.

 

Offer

  • Full-time position (40h/week)
  • An indeterminate contract
  • Attractive salary packing including additional benefits
  • A human-sized working environment with a convivial atmosphere

 

Contact Details

Please apply on the following link MaSTherCell