Automation Lead Job in Rxlogix Corporation

General Purpose:

• Lead all types of software product testing & validation team and 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 & nonfunctional requirements or improvements for software product. Review and ensure that the requirements are detailed, un-ambiguous, complete and testable.
• 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 artefacts including (but not limited to) system testing, functional testing, automation testing, OQ, PQ, IQ, etc.
• Plan, estimate, allocate and review the work performed by the team members, provide feedback to ensure adherence to the validation and documentation practices and be accountable for the quality of work products created by the team.
• Accountable for quality testing and release of all product features and product testing documents / artefacts with high quality.
• Lead validation and UAT activities and artefacts for client product implementation projects.
• Support and liaise with internal QA team for internal and external audits for product / project documents and artefacts.

Minimum Requirements

• Bachelor s degree from like B.Tech., MCA or equivalent course from a good college.
• 6-10 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 high-quality documentation skills
• Self- motivated with ability to handle, organize and prioritize multiple tasks in a dynamic highvolume work environment.
• In depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, GxP and CSV guidelines that are applicable to life sciences industry.

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.