(OQ), and Performance Qualification (PQ) testing. Ensure equipment and systems meet design specifications, user.... Strong understanding of IQ/OQ/PQ processes, GMP regulations, and industry standards (ISPE Baseline Guides, ASTM E2500). Ability to read...
assessment, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports. As member of global engineering...
Qualifications, Operational Qualifications and PQ and process qualifications. Aid the production floor to evaluate and resolve...
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....
and PQ) Participate in teams chartered with commercializing new pharmaceutical products incl. non-sterile, sterile...
development through SAT/IQ/OQ/PQ. Ensure that the procedures and systems are in place to facilitate the introduction of new...
requirement Experience writing and executing validation protocols, including IQ/OQ/PQ documentation Expertise in risk assessment...
for prototype needs, launches, and production. Validate (IQ/OQ/PQ) production processes to meet customer requirements for technical...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports. Act...
protocols (IQ/OQ/PQ) that comply with FDA regulations Troubleshoot technical issues and lead root cause/corrective action...