ppA premier, rapidly growing Swiss CDMO specializing in complex injectable drug products and sterile manufacturing is looking for an experienced bVisual Inspection Subject Matter Expert (SME) /b to join their site in Visp. In this critical technical role, you will act as the primary process owner for visual inspection (VI) operations, driving process robustness, deviation investigations, and regulatory compliance on the shop floor. /p pbJob Title: /b Visual Inspection Subject Matter Expert (SME) /p pbContract Type: /b 6-Month Temporary Contract - , potential extension) /p h3About the Opportunity /h3 h3Key Responsibilities /h3 ul libProcess Ownership: /b Lead visual inspection (VI) processes, driving deviation handling, trend analyses, and workflow standardization to increase inspection robustness. /li libTechnical Investigations Compliance: /b Conduct root cause analyses, manage CAPAs, support batch release preparations, and handle eQMS documentation (Deviations, Change Control, Risk Assessments/FMEA). /li libTraining Defect Libraries: /b Build team capacity by training shop-floor operators and overseeing the creation and maintenance of standardized test sets and defect libraries. /li libNew Product Introduction (NPI): /b Support technical transfers and new product implementations for parenteral container-closure systems. /li libCross-Functional Bridge: /b Serve as the technical link between daily shop-floor operations, QA, MSAT, and senior management. /li /ul h3Your Profile /h3 ul libEducation: /b University degree in Life Sciences or Engineering (Pharmacy, Chemistry, Biotechnology, Process/Mechanical Engineering) or equivalent practical experience. /li libGMP VI Experience: /b Solid background in cGMP environments (EU GMP Annex 1, Data Integrity, GDocP) with hands-on experience in sterile pharmaceutical manufacturing, visual inspection (manual and/or automated), QA, or MSAT. /li libMethodological Tool Expertise: /b Proven skills in Root Cause Analysis, CAPA execution, and Statistical Process Control (Minitab or JMP experience required). /li libTechnical System Knowledge: /b Familiarity with container-closure systems (vials, RTU cartridges/syringes, stoppers), optical/lighting technology, eQMS systems, and MES/ERP (e.g., SAP). /li libLanguages: /b Business fluent / native proficiency in both bGerman /b and bEnglish /b (spoken and written) is mandatory. /li /ul /p #J-18808-Ljbffr
Visual Inspection Subject Matter Expert (SME) Arbeitgeber: Randstad Switzerland
Unser Kunde, ein globaler Pionier in der Pharmaindustrie mit Sitz in Kaiseraugst, bietet eine dynamische und unterstützende Arbeitsumgebung, die auf Innovation und Zusammenarbeit ausgerichtet ist. Mitarbeiter profitieren von flexiblen Arbeitszeiten, der Möglichkeit, im Home Office zu arbeiten, sowie umfangreichen Weiterbildungs- und Entwicklungsmöglichkeiten, um ihre Karriere voranzutreiben. Die Unternehmenskultur fördert Teamarbeit und kontinuierliches Lernen, was es zu einem hervorragenden Arbeitgeber für Fachkräfte im Bereich klinische Studien macht.
