Validation Lead/Manager

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%