Job Description

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.Are you passionate about quality and interested in GxP environments?Join a team where your qualification/validation skills will make a real impact on patients' lives.In order to continue to successfully support our clients, we are currently looking for a Commissioning Qualification & Validation Engineer to work in Lausanne :About the job:Establish and execute qualification protocols; IQ, OQ, PQWrite technical documentation including equipment risk assessments (critical component assessments), Validation Plans, Requirement Tractability Matrices and qualification reportsParticipate in the qualification of systems such as HVAC, Clean Utilities, process or lab equipmentCoordinate qualification execution activities, including external vendors, internal departments, organizing materials, etc.Manage associated qualification deviations & CAPAs, including opening, resolution (with Supplier) and closureContribute to risk assessments and quality improvementsAbout you:Master’s degree in sciences or engineering or equivalent in experience.At least 4 years of experience in equipment qualification (IQ, OQ, PQ)Previous work experience in either the Pharmaceutical, Biotech or Medical Devices sectorGood analytical, organizational, time management and problem-solving skills.Good writing skills. Able to develop and execute DQ, FAT, SAT, OQ, PQ, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines under direct or indirect supervision of the Senior engineering team.Solid knowledge of current FDA and EU regulations and best practicesFrench with good knowledge of EnglishAbout us:Human-sized company with great colleagues from a large diversity of cultural and professional backgroundsWe do care about our people, communicate openly and value feedbackWork as a team where every member is valued and appreciatedOpportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.Continuous learning and development opportunities via internal or external training and workshopsCompetitive salary package in line with industry practice together with exceptional employment benefitsAt 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! Please send us your application.

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