and PQ) and value enhancement opportunities. Ensures ongoing compliance per ISO 13485 and MDSAP requirements Collaborates...
: Job Description: What You’ll Do During the project phase Participate and support testing activities, such as FAT, PQ etc. as well...
supporting equipment qualification (IQ/OQ/PQ). Experience with aseptic processing is a plus. Experience with CDMOs and external...
for components received from suppliers Experience in Process Validation - IQ, OQ, PQ Experience in handling SCAR, RCA, CAPA...
, execution, review, and approval of validation documentation related to optical inspection systems, including IQ/OQ/PQ, inspector...
or Six Sigma certification preferred Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting...
IQ, OQ, PQ, TMV protocols, and validation reports. Monitor complaint trends and quality metrics to identify improvement...
/support process validation activities (IQ/OQ/PQ/PPQ), including TMV. Mentor/lead product team members through the design...
, OQ, and PQ protocols and reports, including deviation and discrepancy resolution. Lead or participate in equipment...
equipment and commissioning. Start-up, installation, or qualification activities. Authoring IQ/OQ/PQ protocols...