Qualification / Validation Engineer M/F
· Master’s degree in scientific or engineering discipline.
· More than 2 years’ experience in equipment qualification IQ, OQ, PQ.
· More than 2 years’ experience in the Pharmaceutical/Biotech sectors.
· Competent with current FDA and EU regulatory regulations and best practices.
· Experiences with GAMP.
· Fluent (professional) in French and English.
· Write and execute qualification protocols; IQ, OQ, PQ.
· Write equipment risk assessments (critical component assessments), Validation Plans, Requirement Tractability Matrix and qualification reports.
· Co-ordinate qualification execution activities, including external vendors, internal departments, organizing materials, etc…
· Manage associated qualification deviations & CAPAs, including opening, resolution (with Supplier) and closure.
· Participate in the creation and review of process Risk Assessments.
· Committed team player.
· Excellent interpersonal skills.
· Flexible, keen to learn, adapt and integrate.
· Excellent communication skills.
Thanks to our extensive experiences, we offer pragmatic solutions in areas such as Quality Asssurance, Regulatory Affairs, Operational Excellence, Engineering, Process Engineering, Manufacturing and Maintenance, Project Management, Human Factors/Usability and trainings... If you have exceptional technical skills, a great personality and you are passionate about serving others, then GXP CONSULTING Switzerland is the right place for you.
Qualified candidates must be legally eligible to work for any employer in Switzerland.
We do not accept unsolicited resumes from recruiters/third parties.
Please submit your application to : firstname.lastname@example.org