IT Quality Validation Consultant
3 weeks ago
Description:
Hybrid
***Please focus on local candidates. Would consider allowing worker to be based out of Exton if strong candidate has that preference.
IT Quality Validation Consultant
Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. Must be familiar with 21 CFR Part 11. Consult on Projects. Prepare Project Plans. BS in a technical field and 5 years experience in GxP environment.
Requirements:
1) Extensive Pharmaceutical Experience.
2) Extensive experience (10 years plus) in writing IT system validation protocols including IQs/OQs/PQs, project summary report. Will consider candidate 5-7 years. 3) Deep understanding of SDLC and IT/system change management processes.
4) Experienced in writing system implementation project related documentation such as project charter, implementation plan, communication plan, risk management plan. 5) BS degree required. Masters's degree preferred.
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
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