Job Opportunity: QA Specialist, CSV & Automation
For our pharmaceutical client based in Visp, we are currently seeking an experienced QA Specialist, CSV & Automation to support large-scale CAPEX projects within a GMP-regulated manufacturing environment.
Job Description
The QA Specialist, CSV & Automation will be responsible for ensuring qualification and validation compliance of equipment and computerized systems associated with aseptic facilities, equipment, and utilities in the GMP manufacturing of drug products, as part of Lonza's CAPEX project portfolio in Stein, AG. Key responsibilities include:
- Ensuring that qualification and validation plans are in place and executed in accordance with Lonza Quality policies for all CAPEX projects from ideation to execution phases.
- Approving SOPs, commissioning, qualification, validation protocols, and related documentation.
- Providing leadership, oversight, and support on qualification and validation topics for ongoing projects.
- Acting as the primary point of contact within GQE for lifecycle and compliance matters related to equipment and computerized systems qualification and validation.
- Managing quality deviations, changes, and CAPAs in a timely manner, leading their resolution while escalating issues when necessary.
Key Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
- Significant experience in the GMP-regulated pharmaceutical industry, preferably in a Quality Unit role.
- Experience in QA roles for CSV and automation of GMP systems related to aseptic fill-finish processes and facilities (such as filling equipment, lyophilization, clean utilities, and clean room facilities).
- Fluency in English; proficiency in German is a plus.
How to Apply
Apply online using the form below. Please note that only applications matching the job profile will be considered.
Contact Information
If you have any questions, please reach out to:
Alba Jansa
Email: alba.jansa@experis.ch
Phone: +41 61 282 22 13
Work locationVisp, Switzerland