Visual Inspection Subject Matter Expert (SME)

Randstad Switzerland; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Randstad Switzerland is seeking an experienced Visual Inspection Subject Matter Expert (SME) for their Visp site. You will own VI processes, drive deviation handling, root-cause analyses, and CAPA execution while ensuring regulatory compliance on the shop floor.

The role also covers training, defect libraries, and support for parenteral container-closure system transfers. Requirements include a university life sciences or engineering degree, GMP/VI experience, and fluency in German and English.

Qualifikationen

• University degree in Life Sciences or Engineering or equivalent practical experience.
• GMP & VI experience in sterile pharma manufacturing with visual inspection.
• Proven skills in Root Cause Analysis, CAPA execution, and SPC (Minitab or JMP).
• Familiarity with container-closure systems and SAP/MES/ERP.
• Fluent German and English, spoken and written.

Aufgaben

• Lead VI processes, drive deviations, trend analyses and workflow standardization.
• Conduct root cause analyses, manage CAPAs, support batch releases and eQMS docs.
• Train shop-floor operators and oversee creation of test sets and defect libraries.
• Support NPI, technical transfers for parenteral containers and closures.
• Serve as the technical link between shop floor, QA, MSAT and senior management.

Kenntnisse

Root Cause Analysis

CAPA execution

Statistical Process Control

Ausbildung

University degree in Life Sciences or Engineering

Tools

Minitab or JMP

SAP

eQMS systems

Jobbeschreibung

A premier, rapidly growing Swiss CDMO specializing in complex injectable drug products and sterile manufacturing is looking for an experienced Visual Inspection Subject Matter Expert (SME) 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.

Job Title: Visual Inspection Subject Matter Expert (SME)

Contract Type: 6-Month Temporary Contract (01.10.2026 - 31.03.2027, potential extension)

About the Opportunity

Key Responsibilities

• Process Ownership: Lead visual inspection (VI) processes, driving deviation handling, trend analyses, and workflow standardization to increase inspection robustness.
• Technical Investigations & Compliance: Conduct root cause analyses, manage CAPAs, support batch release preparations, and handle eQMS documentation (Deviations, Change Control, Risk Assessments/FMEA).
• Training & Defect Libraries: Build team capacity by training shop-floor operators and overseeing the creation and maintenance of standardized test sets and defect libraries.
• New Product Introduction (NPI): Support technical transfers and new product implementations for parenteral container-closure systems.
• Cross-Functional Bridge: Serve as the technical link between daily shop-floor operations, QA, MSAT, and senior management.

Your Profile

• Education: University degree in Life Sciences or Engineering (Pharmacy, Chemistry, Biotechnology, Process/Mechanical Engineering) or equivalent practical experience.
• GMP & VI Experience: 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.
• Methodological & Tool Expertise: Proven skills in Root Cause Analysis, CAPA execution, and Statistical Process Control (Minitab or JMP experience required).
• Technical & System Knowledge: Familiarity with container-closure systems (vials, RTU cartridges/syringes, stoppers), optical/lighting technology, eQMS systems, and MES/ERP (e.g., SAP).
• Languages: Business fluent / native proficiency in both German and English (spoken and written) is mandatory.