QA Specialist / QA Specialistess

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 is responsible for ensuring qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment, and utilities in the GMP manufacturing of drug products within the scope of Lonza's CAPEX project portfolio in Stein, AG. The role entails:

• Ensuring that qualification/validation plans and the execution of equipment, infrastructure, and computerized systems comply with Lonza Quality policies.
• Approving SOPs, commissioning, qualification, validation protocols, and reports, as well as project-related CQV / CSV documents (e.g., URS, FAT/SAT).
• Providing QA leadership, oversight, and support to staff on qualification/validation topics related to ongoing projects, while ensuring the qualification of selected vendors.
• Acting as the first point of contact within GQE regarding the lifecycle and compliance for equipment, infrastructure, and computerized systems qualification/validation, including related documentation in shared global systems (e.g., Kneat, Trackwise, DMS, Unifier).
• Managing quality deviations, changes, and CAPAs/tasks in a timely manner, taking leadership for their resolution when necessary, and escalating issues as needed.

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 the CSV / Automation of GMP systems related to aseptic fill-finish processes and facilities (filling equipment, lyophilization, clean utilities, and clean room environments).
• Fluency in English; proficiency in German would be an advantage.

Apply online using the form below. Please note that only applications matching the job profile will be considered.

Contact

For inquiries, please reach out to:

Alba Jansa
Email: alba.jansa@experis.ch
Phone: +41 61 282 22 13