We are currently looking for an Qualification & Project Specialist to support our team in Fribourg for a period of 1 year.
At this position, you work for the Engineering department in Fribourg and manage the projects and qualification of existing equipment as well as new equipment for Manufacturing, Packaging and Utilities.
Your role will include the following tasks :
Manage the coordination for projects regarding modification on existing equipment or for new ones
Ensure the qualification and the validation of equipment (incl. computerized systems) according to the plan and monitor the qualification status of the equipment
Create, verify and execute equipment qualification plan (FAT / SAT / IQ / OQ / PQ) for equipment
Manage non conformities and CAPA linked to equipment qualification
Create risk analysis documents, technical documentation and SOP
Coordinate cross-functional project teams in order to achieve the goals on-time within the budget
For this challenge, we are searching for a dynamic and social person bringing the following profile :
University degree in engineering or sciences area like chemistry, pharmacy, or similar
First experience within the pharmaceutical or food industry is an asset
Previous experience with equipment validation and project management
Good knowledge of GMP and FDA requirements
Fluency in French and English
You describe yourself as a methodical and autonomous person, able to work efficiently in cross-functional teams. You hold very good communication and organization skills.
Thanks to your analytical thinking, you understand issues from multiple perspectives and see inter-relationships and cause-and-effect relationships.