, and fill finish equipment. Commissioning, Validation & GMP Compliance Detailed knowledge of FAT, SAT, IQ/OQ, and PQ...
/PQ) Lead and direct team in support of customer complaint investigations and/or corrective and preventive actions (CAPAs...
, 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...
, SAT, commissioning, and IQ/OQ/PQ protocols and reports Perform and maintain risk management activities for new...
and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic...
instruments, and contribute to equipment qualification (URS/IQ/OQ/PQ). Own documentation in CMMS with outstanding GDP...
: Supplier pFMEA IQ/OQ/PQ and process validations First Article Inspections and inspection reports Gage R&R and process...
Ability to support IQ/OQ/PQ activities, Environmental monitoring requirements, Internal and external audit responses Reading...
that are equipment related. Aids in IQ/OQ/PQ documents where a service contract is not applicable. Aids in CSV tasks for new...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...