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....
(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...
requirement Experience writing and executing validation protocols, including IQ/OQ/PQ documentation Expertise in risk assessment...
. Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required. Ensure...
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...
installation and qualification (IQ/OQ/PQ) of new machinery, ensuring all equipment is calibrated and integrated into the...
on-time Design Verification and Design Validation and support Process Validation IQ/OQ/PQ/PPQ planning and execution... validation. Experience with IQ/OQ/PQ processes. Familiarity with ISO standards and root cause analysis. Experience in catheter...
you to apply. In this role, you will have the opportunity to: Write and conduct IOQ and spreadsheet validations. Complete PQ, TMV, AQ, and NPSV... and systems. It would be a plus if you also possess previous experience in: Knowledge of PQ, TMV, AQ, NPSV validations...