Job Description

7 - 13 Years
1 Opening
Chennai, Trivandrum

Role description

Requirements:

5 - 8 years of relevant validation experience

Candidates must have working experience with manual testing and preferably also automated testing (selenium based tools).

Candidates must have working experience with system development life cycle and creation and approval of key validation documentation mentioned above.

Candidates must have working experience with reviewing SDLC deliverables and providing feedbacks from a regulatory/validation perspective, pre and post execution review of test scripts, attending stand up calls, and following up with project team on outstanding issues or clarifications.


Candidates must have ability to multi-task and be flexible in a fast paced environment.


Candidates must have excellent communication (verbal and written), ability to multi-task and share ideas on improving efficiency while maintaining regulatory compliance.

Candidates must be able to meet project deadlines.

Must have Clinical/Pharma Industry experience with knowledge of regulatory expectations for computerized systems, 21 CFR Part 11, Annex 11, Data Integrity and Good Documentation Practices.

Working experience with CSV of different GAMP category systems (GAMP cat 3, 4 & 5) Working experience with performing system periodic reviews Hands-on experience working with Waterfall as well as Agile development methodologies Hands-on experience with JIRA and Confluence is preferred

Candidate must be able to work in the UK work shift and must be office-based at least 60% of time.

Skills

Healthcare,Process Validation,Validation Plans

About UST

UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world's best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients' organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact--touching billions of lives in the process.