Your responsibilities:
Ensures that CQV plans of GMP systems are in place and executed by adhering to Lonza Quality policies and applicable SOPs
Ensures that selected vendors are qualified
Approves CQV plans, protocols and reports as well as project related CQV documents (e.g. URS, FAT/SAT, IQ/OQ etc.)
Provide quality oversight on CQV documents as well as related change controls.
Provide leadership and guidance to staff on qualification/validation issues.
Manages Quality deviations, changes and CAPAs/tasks in an open and timely manner, taking leadership for their resolution, but escalating when necessary
Your background:
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 and/ or Engineering role for Clean Utilities related to aseptic fill-finish processes and facilities
#J-18808-Ljbffr