Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.
ABOUT THE JOB:
As a Senior Qualification Engineer you will be providing expertise and support to various clients’ projects on all C&Q activities. You will ensure the C&Q activities are completed safely, as per schedule and in compliance with the system Requirements, Specifications, and project procedures/ guidelines.
* Provide guidance, write, coordinate, review and/or approve all applicable CQV documents in areas such as USP and DSP.
* Actively participate to CQV projects or activities definition, planning or execution.
* Write project documentation (URS, Risk Analysis, Protocols, Reports, Traceability Matrix,…)
* Execute commissioning and qualification validation protocols; FAT, SAT, IQ, OQ, PQ.
* Co-ordinate qualification execution activities, including external vendors, internal departments support, 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
ABOUT YOU:
* Bachelor’s or master’s degree in engineering, Biotechnology, or a related field.
* Minimum of 5 years of experience in writing, reviewing and/or approving C&Q documentation in the biotech or pharmaceutical industry.
* Deep understanding of regulatory requirements and industry standards and methodologies for equipment and utilities qualification.
* Excellent written and verbal communication skills in English. French is a strong asset.
* Strong attention to detail and ability to manage multiple tasks simultaneously.
* Proven ability to work both independently and collaboratively within a team.
ABOUT US:
* We are a Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
* We do care about our people, communicate openly and value feedback
* We work as a team where every member is valued and appreciated
* Professional development and growth opportunities within a dynamic and human focused consulting environment.
* We offer a competitive salary package in line with industry practice together with exceptional employment benefits.
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you!