Assurance, 21 CFR Part 11, EU GMP Annex 11, data integrity/ALCOA+expectations, and client's CSV procedures. Own software... are sequenced correctly, and escalate validation risks and schedule impacts to project leadership. Partner with Quality Assurance...
Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities within a regulated environment..., design/configuration specifications, scripted testing, IQ/OQ, and validation summary documentation. Experience assessing...
, corrective actions, operational readiness, and IQ/OQ/PQ or computer software assurance (CSA)-aligned validation activities... tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring...
Assurance, 21 CFR Part 11, EU GMP Annex 11, data integrity/ALCOA+expectations, and client's CSV procedures. Determine...-live through periodic review and change control. Partner with Quality Assurance, Automation, Engineering, IT/OT...
will provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation..., CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management. The successful candidate...
agreements Preferred qualifications, capabilities, and skills Loan IQ experience. Bachelor's degree in business, in finance... abilities in a dynamic environment. Risk & Control Oversight or Governance Quality Assurance and/or Quality Control Process...
expectations. Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based... pharmaceutical/manufacturing environments. Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control...
Assessments Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Validation Summary.... Facilitate cross-functional collaboration between IT, Cybersecurity, Quality Assurance, Validation, Engineering, Operations...
o Risk Assessments o Installation Qualification (IQ) o Operational Qualification (OQ) o Performance Qualification (PQ..., Cybersecurity, Quality Assurance, Validation, Engineering, Operations, and external vendors. BASIC QUALIFICATIONS: Minimum...
valuation Prior experience with platforms such as Salesforce, Pitchbook, S&P Capital IQ Series 79 and Series 63 licenses... accounting firms in the United States, our 7,000+ team members deliver assurance, tax, and consulting services to clients...