QA Specialist, CSV & Automation

Job Title

QA Specialist, CSV & Automation

The QA Specialist, CSV & Automation is responsible for the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products as part of Lonza CAPEX project portfolio in Stein, AG. Responsible for the compliance of commissioning and qualification of large CAPEX projects (e.g. new drug product facility) from ideation to execution phases, throughout all design phases:

• Ensures that qualification/validation plan and execution of equipment, infrastructure and computerized systems are in place by adhering to Lonza Quality policies.
• Approves SOPs, commissioning/qualification/validation protocols and reports as well as project related CQV/CSV documents (e.g. URS, FAT/SAT, etc.).
• Provides QA leadership, oversight and support to staff on qualification/validation topics related to ongoing projects and ensures that selected vendors are qualified.
• Acts as first point of contact within GQE for any area related to the lifecycle and compliance for equipment, infrastructure and computerized systems qualification/validation, including documentation in shared global systems (e.g. Kneat, Trackwise, DMS, Unifier, etc.).
• Manages Quality deviations, changes and CAPAs/tasks in an open and timely manner, taking leadership for their resolution, but escalating when necessary.

• Bachelor or Master’s degree in Engineering, Life Sciences or 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 facility (filling equipment, lyophilization, clean utilities, and clean room facilities).
• Fluent in English;
  German would be an advantage.

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.

Contact:
Alba Jansa
alba.jansa