Duties: Supporting medical device processes, equipment changes, and validations (IQ/OQ/PQ) to meet regulatory standards...
. Review and schedule preventive maintenance and other scheduled compliance activities (OQ, PQ and validation) and dispatch...
supplies, fuses etcetera Basic electrical knowledge GxP experience with instrument PM protocols, IQ, OQ, PQ and controlled...
and qualification of fixtures, tooling, equipment and systems to support operations. Support IQ, OQ, and PQ validation studies...
activities with Quality- IQ/OQ/PQ. Determine tooling and equipment needs for the timely and cost-effective manufacture...
, PQ) Process capability (cpk). Understand statistics and how it impacts statistical control over process. Lead Supplier...
with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ). Strong problem-solving skills include root...
assessment, IQ-OQ-PQ protocols, trace matrix and summary reports). Experience in validating GMP Lab systems and Equipment...
for Quality control systems, IT validations, performing IQ/OQ/PQ, qualification etc.,) Any new IT initiatives implementation... platforms. Performing IQ/OQ/PQ as per validation requirements. Support FDA and other audits from IT Admin perspective...
and Standard Operating Procedures, and related documentations;and overseeing the functional and validation testing, IQ/OQ/PQ...