What are the responsibilities and job description for the Testing and Compliance Lead position at Quantum Integrators?
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.