QA Specialist CAPEX (m/f/d) 100%

For Lonza AG in Stein AG we are looking for a QA Specialist in CAPEX. This role is temporary for minimum of 12 months.

Lonza AG is a global leader in the life sciences industry, with a significant site located in Stein, Switzerland. This site specializes in the manufacturing and development of active pharmaceutical ingredients (APIs) and the aseptic filling and production of sterile medications. Lonza Stein offers comprehensive services for the pharmaceutical and biotechnology sectors, including process development, manufacturing, and quality control. Equipped with state-of-the-art technologies and stringent quality standards, the site plays a vital role in the supply of essential medicines, supporting clients in the execution of complex pharmaceutical projects.

responsibilities:

• 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