Validation Lead Job in Rxlogix Corporation

Validation Lead

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Job Summary
    General Purpose:
  • Lead all types of software product testing & validation activities
  • Lead the testing / validation team for internal software development process
    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 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
Experience Required :

7 to 10 Years

Vacancy :

2 - 4 Hires

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