. Partner with Engineering and Validation teams to ensure facility and utility qualification (IQ/OQ/PQ) programs adequately... of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality — with at least 4...
with approved GMP procedures and qualification protocols. Review and execute IQ, OQ, and other equipment qualification protocols..., Manufacturing, Quality Assurance, and equipment vendors to ensure equipment readiness. Support equipment turnover and readiness...
equipment, utilities, facilities, and systems. Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation..., Automation, Manufacturing, Quality Assurance, Facilities, and external vendors. Provide technical leadership and mentoring...
manufacturing environment and combines both Quality Engineering and Quality Assurance responsibilities. You investigate... for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Review drawings, procedures...
Specifications Risk Assessments Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ..., Quality Assurance, Validation, Engineering, Operations, and external vendors. BASIC QUALIFICATIONS: Minimum Education...
for the Quality Assurance Systems Engineer position. Important: This position is located in Medina, NY and is designed... Systems Manager, the primary responsibilities are: Support and execute complex validations, including IQ, OQ, PQ, and MSA...
, reliability, and repeatability. Lead validation activities for new products and technologies, including IQ, OQ, and PQ phases... assurance and quality management principles. Proven ability to drive continuous improvement and process improvement initiatives...
or existing parts, including PPAP and IQ/OQ/PQ, where applicableUsing Six Sigma, including PCDA, SPC, and DOE to improve... and constructive debate, to hold others accountable.Desired Qualifications:Extensive familiarity with quality assurance processes...
, or Capital IQ is a plus. Experience working with large datasets is a plus. Ability to work within a given budget and schedule... of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled...
, and sterility assurance. Support scale-up and technology transfer from development to commercial manufacturing. Qualification..., Validation & Lifecycle Management Support and/or lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems...