(SIA, URS, RA, FAT, SAT, VP, IQ, OQ, PQ, TM, PPQ) as well as the generation of corresponding summary report Achieve...
& Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports...
. Support equipment qualification (IQ/OQ/PQ) and lifecycle management. Provide calibration input into risk assessments, URS...
, OQ, and PQ protocols in compliance with GMP and regulatory requirements. Assist with startup, troubleshooting, testing... within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. Working knowledge of IQ/OQ/PQ...
Requests and align on validation requirements with associated CFT members. Draft and approve validation protocols for IQ/OQ/PQ...
. Perform process validation (IQ/OQ/PQ/MVP/TMV) and gage R&R activities, as required. Ensure bill of materials and job router...
and compliance strategy across IQ/OQ/PQ activities, maintaining the highest levels of regulatory integrity across the LP1 digital...
resources in the equipment specification, procurement, and IQ/OQ/PQ Participation with internal and CM resources to assess the...
: Job Description What You’ll Do During the project phase Participate and support testing activities, such as FAT, PQ etc. as well...
, specify, select, validate (IQ/OQ/PQ), and implement new/existing molds and IMMs for manufacturing. Monitor performance...