Validation Lead/Manager

General Purpose : Lead all types of software product testing & validation activities Lead the testing / validation team for internal software development process Lead the testing / validation team for external client implementation projects Essential Duties & Responsibilities : Interact with internal product owners and client users to understand business, functional & non-functional requirements or improvements for software product. 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 artifacts including (but not limited to) system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, etc. Accountable for quality testing and release of all product features and product testing documents / artefacts with high quality. Lead validation and UAT activities and artifacts for client product implementation projects. Support and liaise with internal QA team for internal and external audits for product / project documents and artifacts. Minimum Requirements : Bachelor’s degree from a good college like B.Tech., B.IT or similar 5-8 years of total experience in software industry in all kinds of testing activities and SDLC documentation with at least 2-3 years in life sciences domain. At least 2-3 years’ experience of leading high performing testing teams of 4-8 members. In depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, GxP and CSV guidelines that are applicable to life sciences industry Well-organized and detailed oriented professional, with strong communication and high-quality documentation skills Self- motivated with ability to handle, organize and prioritize multiple tasks in a dynamic high-volume work environment. Preferred Qualifications: Good knowledge of Drug Safety (Pharmacovigilance) domain Knowledge of a leading Drug Safety System like Argus Safety, ArisG, etc. Experience of working with enterprise software application Working knowledge and experience of Oracle Database, Agile/JIRA, Confluence Audit experience in supporting IT related systems/Client Interactions Travel Expectations: 0-25%