R&D Manager
for medical devices or comparably regulated environment is required. Experience in process validation (IQ, OQ and PQ), writing...
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...
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...
. 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...
using IQ/OQ/PQ validation techniques Approves supplier test and inspection plans and procedures to ensure quality at the... environment Working knowledge of PPAP and IQ/OQ/PQ validation techniques Strong written and verbal communication skills Direct...