Validation Lead/Manager
rxlogix· Professional Services
About this role
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%
Frequently Asked Questions
Is the salary disclosed for the Validation Lead/Manager position at rxlogix?
The salary for this Validation Lead/Manager role at rxlogix is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Validation Lead/Manager position at rxlogix located?
This Validation Lead/Manager role at rxlogix is based in Noida, Uttar Pradesh, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Validation Lead/Manager role at rxlogix full-time or part-time?
This is listed as a Full Time position. It is posted as a Validation Lead/Manager role in the Professional Services department at rxlogix.
Which team or department does the Validation Lead/Manager at rxlogix belong to?
This Validation Lead/Manager position is part of the Professional Services department at rxlogix. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Validation Lead/Manager position at rxlogix?
Click the "Apply Now" button on this page. You will be redirected to rxlogix's official application portal hosted on bamboohr where you can submit your application directly.
When was the Validation Lead/Manager job at rxlogix posted?
This Validation Lead/Manager position at rxlogix was posted on Jun 16, 2022. Apply as soon as possible — early applications are often reviewed first.
Validation Lead/Manager
rxlogix
You'll be redirected to rxlogix's official application page on bamboohr.