Full Description

Company Profile: Quantum Integrators is an international strategy and business consulting group whose mission is to help clients create and sustain competitive advantage. As a truly client-focused firm, our highly trained and experienced consultants consider it their mandate to help client organizations achieve a 'quantum state.

Position: Testing & Compliance Lead

Location: Raritan, NJ – Hybrid, 3-4 days onsite

Duration: Contract (W2 or Own Corp only)

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

Job Description

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.