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
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