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Gais, Appenzell Ausserrhoden, Schweiz/Suisse/Svizzera/Svizra
Onsite
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Job Description
PerkinElmer's OneSource team is looking for a Validation & Compliance Engineer to join our team in Schachen, Switzerland.
In this role You'll review and approve documentation for calibration, maintenance, and repair activities, release assets for use, and manage changes, deviations, and CAPAs — working closely with Calibration & Maintenance Engineers to keep everything GxP-compliant.
More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer
Document Review & Approval / Asset Release
Reviews and approves documents as part of calibration, maintenance, and repair work
Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDP gaps in provided documentation
Releases assets after successful completion of calibration, maintenance, and repair work
Processes Changes, Temporary Changes, Deviations, and CAPA related with calibration and maintenance
Contributes to changes and investigations as a member of cross-functional teams
Data Management / Administrative Release
Adds, updates, reviews, and releases positions in the Customer calibration/maintenance databases (CCMS/CMMS)
Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems
Requirements
Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
Minimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
Knowledge of cGMP, Annex 1 and validation regulations and requirements.
Knowledge of GMP, GLP, GDP, pharmacopeia and regulatory requirements preferred.
Developed Customer service mindset
Be passionate about detail and tech aspects
Strong written and verbal communication skills.
Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.
Join our Team!
We are strongly committed to the development of your career and giving you opportunities to learn and grow.
We make a difference for you while you make a difference in the world!