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...
and approve qualification/validation documents for equipment and process (i.e., IQ/OQ/PQ). Review and approve Performance... systems Previous investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control...
Job Description: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols...
documentation, validation plans, process verification and validation documentation including TMV and OQ/PQ etc.). Collaborates...