development through SAT/IQ/OQ/PQ. Ensure that the procedures and systems are in place to facilitate the introduction of new...
protocols and reports (Le IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparatiori of specifications...
. Mandatory IOQ experience with Filter Press or Centrifuge (one required). Hands-on execution of IQ, OQ, PQ for capital projects...
, traceability matrices, and validation reports. Execute IQ/OQ/PQ testing, risk assessments, ALCOA+ evaluations, and change control.../PQ, requirements development, test execution, and traceability. - Familiarity with integrations between MES and ERP...
requirement Experience writing and executing validation protocols, including IQ/OQ/PQ documentation Expertise in risk assessment...
of validation deliverables including traceability matrices, IQ/OQ/PQ protocols, and validation reports. Conduct performance, load...
for medical devices or comparably regulated environment is required. Experience in process validation (IQ, OQ and PQ), writing...
with regulatory and internal requirements. Execute and support process validation activities including IQ, OQ, and PQ. Lead... validation activities (IQ, OQ, PQ). Strong documentation, verbal, and written communication skills....
reports. Execute IQ/OQ/PQ testing, risk assessments, data integrity (ALCOA+) evaluations, and change control activities... records, deviations, CAPAs, and data integrity (ALCOA+). Experience with system validation including IQ/OQ/PQ, requirements...
in regulated environments. Evidenced hands-on technical curiosity. Experience in process validation (IQ, OQ and PQ), writing...