on all the Program Top Hats until hand over with the project dedicated team Perceived Quality (PQ) Management: ensure PQ...
and interpretation of process DOE’s (mini-tab preferred), GR&R, IQ/OQ/PQ, Fishbone, etc. is required Demonstrated experience working...
with Discovery and Engineering during Prototyping, Engineering Evaluation, V&V, and PQ/PV. ADDITIONAL RESPONSIBILITIES...
deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability...
in validation activities (IQ/OQ/PQ) and maintain compliant documentation (SOPs, work instructions) Ensure adherence to FDA QMSR...
, Process Maps, other Engineering and Quality related processes. Knowledge of Validation (IQ, OQ, PQ) Computer skills: Word...
and provide feedback on SFMD supplier IQ/OQ/PQ, test method validations (ATMV/VTMV), and PFMEA content Providing onsite training...
(Computer System Validation) activities into OT/MES schedules Schedule IQ/OQ/PQ, or similar, activities for automation...
on process development and process validation including IQ/OQ/PQ/TMVs. Initiate and execute part qualification plan and reports...
qualification and validation (IQ/OQ/PQ) in a GMP-regulated manufacturing environment. Other Information: ~15% travel...