| CSV Consultant with Mergers and Acquisition experience :: Raritan, NJ (onsite) at Raritan, New Jersey, USA |
| Email: [email protected] |
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Greetings from Shrive Technologies LLC!! Shrive Technologies LLC is an IT Development & IT Staffing firm with more than a decade of experience in providing IT Staffing Solutions & Services. Our expertise is in sourcing and deploying highly skilled IT Specialists into mainstream and niche technologies to meet clients Temporary, Permanent & SOW project needs. Role: CSV Consultant with Mergers and Acquisition experience Location: Raritan, NJ (onsite) Duration: Long term Mandatory skills : Computer System Validation, Quality Management System, Acquisitions and Mergers Roles and Responsibilities Minimum 9 years Experience in the Validating IT software systems like Quality Management System in Life Sciences industry Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation. Experience in validating Global Risk and Compliance modules Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality Knowledge of FDA guidances and industry standards Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports) Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival process Hands-on experience in software life-cycle management in System data archival process Ability to provide Validation guidance, timely reviews, and escalations to Project teams -- Thanks & Regards, Naren Email: [email protected] -- To post to this group, send email to [email protected]. Keywords: information technology New Jersey |
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| 10:11 PM 22-Jan-24 |