Pharmaceutical Quality Assurance Engineer

Pharmaceutical Quality Assurance Engineer

My client is a growing pharmaceutical company based in the French part of Switzerland looking to expand their quality team.

Due to this growth, my client is looking for a Quality Assurance engineer with strong experience in design, qualification and validation to join their team.

Responsibilities:

•  Commissioning and Qualification of the utilities and process equipment.
•  Act as the point of contact for quality compliance topics regarding Process Equipment
•  Risk assessment exercises
•  Review and approve Process Equipment to ensure compliance with cGMP and applicable regulations
•  Support the Commissioning & Qualification activities during FAT at suppliers and on site
•  Create SOPs for Process Equipment qualification / validation
•  Conduct supplier’s audit as well as self-inspections
•  Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams

Your Profile:

•  Fluent in English and French
•  minimum of 5 years in a quality assurance engineering role in a manufacturing environment
•  Knowledge of biotechnological technologies
•  Proficiency in good practice requirements GMP as well as regulations and standards related to qualification and validation
•  Experience in health authorities inspections
•  Strong result orientation and committed team member
•  Flexibility and ability to travel up to 25% during project
•  Strong experience of Quality Assurance engineering and specifically on qualification and validation activities

 

Please send your CV in English to Jean de La Fournière at jean@axepta.com

Jean De La Fourniere delafourniere@axepta.com