Validation Lead Consultant @ Rxlogix Corporation

• 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 of testing and release of all product features and product validation documents / artefacts with high quality.
• Exposure to Agile scrum structure and project tracking tools like Atlassian JIRA
• Support and liaise with internal QA team for internal and external audits for product / project documents and artifacts.

Minimum Requirements:

• Bachelor's/Masters degree from a good college like B.Tech., MCA, etc.
• 7-10 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.
• Well-organized and detailed oriented professional, with strong communication and highquality documentation skills
• Self- motivated with ability to handle, organize and prioritize multiple tasks in a dynamic
  high-volume work environment.
• Analytical and process-oriented mindset

Preferred Qualifications

• Good knowledge of Drug Safety (Pharmacovigilance) domain
• Knowledge of a leading Drug Safety System like Argus Safety, ArisG, etc.
• Led the testing / validation team and activities for external client implementation projects
• Client facing experience
• Experience of working with enterprise software application
• Working knowledge and experience of Oracle Database, Agile/JIRA, Confluence
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, GxP and CSV guidelines that are applicable to life sciences industry
• Audit experience in supporting IT related systems/Client Interactions