Validation Lead/Manager

18 hours ago

Noida Uttar Pradesh India RxLogix Corporation Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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%

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