Job Opportunity: QA Specialist, CSV & Automation
We are currently seeking an experienced QA Specialist, CSV & Automation for our pharmaceutical client based in Visp. This role entails supporting large-scale CAPEX projects within a GMP-regulated manufacturing environment.
Job Description
The QA Specialist, CSV & Automation is responsible for ensuring qualification and validation compliance of equipment and computerized systems related to aseptic facilities, as well as equipment and utilities within the GMP manufacturing of drug products. This is a vital role within the Lonza CAPEX project portfolio in Stein, AG. Key responsibilities include:
- Ensuring that qualification/validation plans and the execution of equipment, infrastructure, and computerized systems are in accordance with Lonza Quality policies.
- Approving SOPs, commissioning/qualification/validation protocols, reports, and project-related CQV / CSV documents (e.g. URS, FAT/SAT).
- Providing QA leadership, oversight, and support on qualification/validation topics related to ongoing projects, ensuring selected vendors meet qualification requirements.
- Serving as the first point of contact within GQE for matters related to the lifecycle and compliance of equipment, infrastructure, and computerized systems qualification/validation, including documentation in shared global systems (e.g. Kneat, Trackwise, DMS, Unifier).
- Managing Quality deviations, changes, and CAPAs/tasks proactively, taking the lead on their resolution while escalating 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 role within a Quality Unit.
- Experience in a QA role for CSV/Automation related to GMP systems, especially in aseptic fill-finish processes and facilities (including filling equipment, lyophilization, clean utilities, and clean room facilities).
- Fluency in English; proficiency in German is an advantage.
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, feel free to reach out to:
Alba Jansa
alba.jansa@experis.ch
+41 61 282 22 13