in our production lines. Must Have Experience in equipment IQ Experience in OQ (Operational Qualification) and PQ (Performance...
activities for laboratory instruments and systems, including IQ/OQ/PQ execution and protocol development Support qualification... Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, deviations, and change controls Perform impact...
quality, product quality metrics, and reporting analytics Drive APQP, PPAP, and validation activities (IQ/OQ/PQ) for new...
, and facilities (IQ, OQ, PQ). Recommend improvements to systems, equipment, and processes to enhance quality and reliability...
work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP... Must Have: Hands-on validation engineering or CQV experience. Strong OQ/PQ execution and documentation background. Fill/finish...
process validations including IQ/OQ/PQ Conduct DOE studies, SPC analysis, root cause investigations, and process capability.../PQ, DOE, SPC, PFMEA, and Minitab Strong troubleshooting and problem-solving skills This is an excellent opportunity...
/OQ/PQ development, data evaluation, and risk reviews. Lead development and execution of supplier APQP processes...
actions Support new and transferred projects using APQP, PPAP, and IQ/OQ/PQ methodologies Lead and develop the Quality team...
, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met. Serve as the on-site/day... documentation controls that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA...
activities and manage NCRs, CAPAs, and corrective actions Develop and execute process validations (PFMEA, OQ/PQ, PPAP, FAIR...