Jobdescription
For our client, we are seeking a Process Specialist to coordinate and execute site activities within the MSAT (Manufacturing Science and Technology) department.
Your Role :
* Coordinate with the project stakeholders the site activities for new product introductions, technology transfer (TT), validation of processes or process changes for commercial products.
* Ensure coordination of production activities on the shop floor falling under your responsibility.
* Write documentation related to process validation, change controls and batch record for the manufacturing of products under your scope.
* Lead investigations and troubleshooting efforts in collaboration with quality and production teams.
* Develop and maintain strong relationships with internal stakeholders including production, Quality unit, and technical services.
* Ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo, GLIMS), ERP (SAP).
* Ensure that all related activities are carried out at required quality / GMP standards
Qualifikationen
* Master or Engineering degree in Biotechnology, Process, Pharmacy, or a related field.
* Over 3-5 years of experience within a manufacturing environment.
* Strong understanding of GMP regulations and compliance requirements from health authorities.
* Good communication skills in both French and English, with the ability to engage effectively with diverse teams.
* Ability to work with autonomy establishing internal/external contacts for successful accomplishment of her/his tasks.
* A proactive mindset with a commitment to fostering continuous improvement and innovation in processes.