Consulting

Validation Lead
Miami, Florida, US, Noida and Bangalore, India
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Date: 9th June 2020

Job Status: Full Time

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

Travel Expectations
0%- 25% travel