Job Status: Full Time

Essential Duties & Responsibilities

Note: This prospect is not a fit for the software testing professionals. The candidate must possess experience in the Pharmaceutical IT Compliance areas and CSV and a good understanding of regulations for LifeScience industries such as GAMP 5, CFR , EU Annex 11, ICH etc.

CSV:
Provide application validation expertise on GxP products for drug safety space.
Be accountable for reviewing and supporting key CSV deliverables – Requirement
Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report,
Qualification Scripts and Validation Summary Report
Understanding of implementing projects on SaaS Models
Interact with internal product owners and client users to understand business, functional & non-functional requirements or improvements for software product.
Review and ensure that the requirements are detailed, un-ambiguous, complete and testable.
Author and/or review validation test plan, strategy, requirement traceability matrix,



validation test summary report for product releases based on project / product requirements.
Lead, mentor & guide the testing team members for all type of testing activities and artefacts including (but not limited to) system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, etc.
Review the work performed by the team members, provide feedback to ensure adherence to the validation and documentation practices and be accountable for the quality of work products created by the team.
Accountable for quality testing and release of all product features and product testing documents / artefacts with high quality.
Lead validation and UAT activities and artefacts for client product implementation projects.
Support and liaise with internal QA team for internal and external audits for product / project documents and artefacts.
Understanding needs of Infrastructure , Operation and Performance qualification in alignment with Software Engineering

📌 Team Lead – IT QA (Noida)
🏢 RxLogix
📍 Noida