, and IQ/OQ/PQ. Monitor yields, troubleshoot production issues, and drive corrective actions. Conduct performance reviews...-on experience with validation (IQ/OQ/PQ) and process documentation. Knowledge of FDA 21 CFR 820, ISO 13485, and international...
periodic reviews of validated systems. Assist in developing and executing validation protocols (IQ/OQ/PQ) for computer...
qualification (IQ, OQ, PQ). Develop, review, and execute validation protocols and reports in compliance with GMP standards...
customers. You’ll lead continuous improvement efforts, develop and validate robust manufacturing processes (IQ, OQ, PQ, gauge... or updated assembly procedures to ensure smooth production readiness. Lead process validation activities, including IQ, OQ, PQ, gauge R&R...
qualification (IQ, OQ, PQ). Develop, review, and execute validation protocols and reports in compliance with GMP standards...
processes (IQ/OQ/PQ) Experience in building an organization Support of a 24/7 production operation Experience in an FDA...
integrations, and equipment validation. Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ...
operating procedures. Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master... Analysis, FMEAs), leading design verification and validation testing, and executing process validations (TMV, IQ/OQ/PQ Working...
compliance Complaint handling and post-market surveillance Validation (IQ/OQ/PQ) Regulatory compliance strategy... protocol development (IQ/OQ/PQ). Experience with electronic QMS systems preferred. Ability to operate effectively...
resources in the equipment specification, procurement, and IQ/OQ/PQ Participation with internal and CM resources to assess the...