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%