Validation Lead/Manager
RxLogix CorporationNoida, Uttar Pradesh, India
Posted June 16, 2022
Full Time
About the Company
RxLogix Corporation delivers end‑to‑end pharmacovigilance solutions powered by machine‑learning and artificial‑intelligence, enabling pharmaceutical companies to detect, evaluate, and manage safety signals with greater speed and accuracy. Their flagship PV Surveillance Suite—comprising PV Reports, PV Signal, PV Analytics, and PV Datahub—was selected by the FDA to replace the legacy FAERS system, underscoring its regulatory credibility and advanced analytics capabilities. By integrating best‑practice methodologies across the drug‑safety value chain, RxLogix boosts compliance, productivity, and patient safety for its clients. The company fosters a culture of bold, science‑driven innovation, continuously seeking pre‑emptive solutions to complex safety challenges. RxLogix’s blend of cutting‑edge technology and deep industry expertise makes it a distinctive partner for life‑sciences organizations seeking proactive risk management.
Job Description
Lead all types of software product testing & validation activities, lead the testing / validation team for internal software development process and external client implementation projects.
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