PerkinElmer's OneSource team is looking for a Manufacturing Asset Specialist to support the Team on Customer site (MSD) in Schachen.
MoreinformationaboutPerkinElmer and our business : PerkinElmer | Science with Purpose
More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer
Hybrid working model
Responsibilities:
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 GDocP gaps in provided documentation
- Releases assets after successful completion of calibration, maintenance, and repair work
- Processes 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 asset records 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
- 3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
- Operator process specialist experience
- Bachelor’s degree in a Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
- Knowledge of cGMP and validation regulations and requirements
- Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred.
- Strong written and verbal communication skills in English (required), German (strongly preferred).
- Developed Customer service mindset
- Be passionate in attention to detail and tech aspects
- Ability to work both independently and as a team member, adapt to changing environment
- Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic
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!
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Manufacturing Asset Specialist in Schachen Arbeitgeber: PerkinElmer
Als Arbeitgeber bieten wir Ihnen ein flexibles hybrides Arbeitsmodell mit minimalen Vor-Ort-Anforderungen, das Ihnen die Möglichkeit gibt, Ihre Arbeitsweise selbst zu gestalten. In dieser abwechslungsreichen Rolle als Business Administrator haben Sie die Chance, echte Verantwortung zu übernehmen und operative Prozesse aktiv zu gestalten und zu verbessern. Unsere kollaborative und funktionsübergreifende Arbeitsumgebung fördert nicht nur den Austausch von Ideen, sondern auch Ihre persönliche und berufliche Weiterentwicklung.
