In the context of an increase in activity, one of our clients, a young and dynamic Swiss company specialized in high-precision filling of complex sterile drugs into vials, syringes, and cartridges, is looking for a Qualification Engineer, in the canton of Valais.
This company is a young company with 60 employees, they are specialized in the pharmaceutical industry.
As a qualification engineer, you are responsible for planning and managing qualification projects and for meeting deadlines, costs, and quality standards.
Your main responsibilities:
– Prepare the documentation for re-qualifications and qualifications according to GMP and GAMP for phases IQ – OQ – PQ
– Participate in the FATs / SATs phases
– Work on the continuous further development of the qualification concept, incorporating changes to the applicable standards, guidelines, and technical developments
– Create SOP and procedural instructions to ensure compliance
– Conduct qualification reviews
– Represent the department during audits and inspections
– Support the identification of causes, technical evaluation and processing of deviations and cooperate in the procedural planning of project changes
To lead this mission, we are looking for a profile with:
– Engineering degree or equivalent in mechanical, pharmaceutical or chemical engineering
– Minimum 3 years experience in the field of plant qualification, validation of computerized systems as well as GMP and GAMP
– You are flexible and open to new ideas and can adapt well and quickly to changing circumstances
– Strong verbal and written communication skills
– Capacity for teamwork
– German and English in written and spoken
– You are looking for a new challenge in which you can contribute your experience and make a significant contribution to the success of the company