Testing & Compliance Lead - Veeva RIMS

Location: Raritan, NJ, USA - Onsite

Skills: 10+ years of experience in Testing & Compliance Lead with good understanding in Veeva RIM

Long Term Project

Role & Responsibilities:

Associate must develop and implement comprehensive test plans and strategies for various Veeva RIMS modules.
Ensure all testing and validation activities adhere to life sciences industry standards.
Oversee system validation and compliance documentation.
Aware of the Veeva RIMS business functionalities like Registrations , Submissions , XEVMPD , Labelling ,
Fair experience in testing Veeva Integrations with external applications using API and leveragings tools like postman.
Well versed in all forms of reporting like DSR, WSR, MBR, creating Jira dashboards etc
Work closely with the offshore counterpart and communicate the status and issues openly and clearly with the customer as well as other stakeholders
Proactively identify and assess quality risks, devise mitigation plans and contingency plans.
Lead defect triage meetings, manage the lifecycle of defects, Support the End Users at onsite during UAT.
Should be equipped to train the users on JIRA and Veeva RIMS during UAT Phase
A strong understanding of the life sciences domain and regulatory standards like GxP and 21 CFR Part 11.
Manage & review compliance deliverables, validation plan, validation summary report, RTM etc.