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 the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment, and utilities involved in the GMP manufacturing of drug products. This role is part of the Lonza CAPEX project portfolio in Stein, AG, and includes oversight throughout all phases of design and execution.
Key responsibilities include:
- Ensure that qualification and validation plans, as well as the execution of equipment, infrastructure, and computerized systems, comply with Lonza Quality policies.
- Approve SOPs, commissioning, qualification, and validation protocols and reports, along with project-related CQV/CSV documents (such as URS, FAT/SAT, etc.).
- Provide QA leadership, oversight, and support to staff on qualification and validation topics related to ongoing projects, ensuring that selected vendors are qualified.
- Act as the primary point of contact within GQE regarding the lifecycle and compliance for equipment, infrastructure, and computerized system qualification/validation, including documentation in shared global systems (e.g., Kneat, Trackwise, DMS, Unifier, etc.).
- Manage Quality deviations, changes, and CAPAs/tasks in a timely manner, taking leadership for 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 within a Quality Unit.
- Experience in a QA role for the CSV/Automation of GMP systems related to aseptic fill-finish processes and facilities (including filling equipment, lyophilization, clean utilities, and cleanroom facilities).
- Fluent in English; knowledge of German would be an advantage.
Apply online using the form below. Please note that only applications matching the job profile will be considered.
Contact
Alba Jansa
Email: alba.jansa@experis.ch
Phone: +41 61 282 22 13