Alpha Consulting Corp

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices. Knowledge and experience in utilizing Change Management Applications i.e. ServiceNow, Infinity, Veeva, Valgenesis,. Experience in leading investigations and initiating deviations and Change Control activities.. Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity).. Familiarity with DCS systems (i.e. Emerson DeltaV, Rockwell SCADA, ERP systems (i.e. SAP or Oracle), and Historians (i.e. OSIsoft PI).

quality compliance specialist

IT Quality & Compliance Specialist Libertyville, IL 100 % onsite  Pay: $50-$52.44 The candidate  must have experience in configuring, troubleshooting, and setting up equipment to communicate with the network. Must be mentioned in the resume.  Job description:<ul><li>Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.</li><li>Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.</li><li>Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices</li><li>Knowledge and experience in utilizing Change Management Applications i.e. ServiceNow, Infinity, Veeva, Valgenesis,</li><li>Experience in leading investigations and initiating deviations and Change Control activities.</li><li>Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.</li><li>Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity).</li><li>Familiarity with DCS systems (i.e. Emerson DeltaV, Rockwell SCADA, ERP systems (i.e. SAP or Oracle), and Historians (i.e. OSIsoft PI).</li></ul>

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