Ability to support IQ/OQ/PQ activities, Environmental monitoring requirements, Internal and external audit responses Reading...
, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. Exposure to Regulatory Audits and Remediation activities... and knowledge in any one of the QC/R&D Lab systems is must. Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
/PQ) Lead and direct team in support of customer complaint investigations and/or corrective and preventive actions (CAPAs...
of GD&T and ability to read engineering drawings Understanding of process validations (IQ, OQ, PQ) and manufacturing...
: Supplier pFMEA IQ/OQ/PQ and process validations First Article Inspections and inspection reports Gage R&R and process...
instruments, and contribute to equipment qualification (URS/IQ/OQ/PQ). Own documentation in CMMS with outstanding GDP...
systems is highly desirable Utilizing relay secondary injection test sets PQ measurements Leading crews to test...
and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic...
, and fill finish equipment. Commissioning, Validation & GMP Compliance Detailed knowledge of FAT, SAT, IQ/OQ, and PQ...