. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards. Lead the technical execution acquisition... in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred. Communication Skills: Strong ability...
and/or review validation documentation including Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ...
for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining...
of required trainings that address diverse learners. PQ Registry must remain current and reflect all PD hours, trainings and college level...
Testing), SAT (Site Acceptance Testing), IQ, OQ, PQ, Test Scripts, MSA (Measurement System Analysis), Process Development...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
of manufacturing process validation (FAI/FAT, IQ/OQ/PQ), strong analytical and problem-solving skills, with proficiency in Microsoft...
for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining...
(21 CFR Part 820, GxP, CSV) and IQ/OQ/PQ testing protocols for validated systems. Experience with ERP systems, SaaS...