Job Description :
Job Description:

- Candidate should be willing to work flexible shift timings.
- Should have experience working with Global clients.
- Should have 4+ years of relevant experience in validating Computerized Systems.
- Well acquainted with all the phases of System Development Life Cycle (SDLC) and GAMP methodologyKEY RESPONSIBILITIES: -

Develop Change strategy, test cases & test plans
Responsible for driving SDLC deliverables to completion. Interacting with business owner, technical lead and quality assurance to address comments to achieve approval.
Support testers by providing guidance on scripts during execution or other SDLC documentation.
Clearly communicate analyzed gaps in process or documentation to management and team leads.
Participate in requirements gathering and provide sound feedback.
Manage, Control & review IQOQ documentation and ensure IQOQ documents are stored in client repositories as per policy standards.
Ensure the content in Change Records are clear to stand as evidence for any audit requirements.

SKILLS REQUIRED: -

Must have good attention to detail and ability to adhere to protocol, revenant SOPs and supporting documentation.
Extensive validation experience in 21 CFR Part 11.
Expertise in following GxP standards, Data Integrity and Good Documentation Practices.
Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.
Good communication skills and English fluency both written and verbal.
Change Management experience (functional, usability, regression, performance, exploratory
Good written and verbal communication skills.
Ability to work independently with minimal direction.
Bachelor’s degree in Computer Science or equivalent.
Strong personality - experience client-facing with Stakeholders and key Business Units and other IT teams.
Identify areas for process improvement

Remedy/ ServiceNow Experience a plus


Client : HCL America

             

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