Computer System Validation(CSV) Consultant/Analyst_Contract To Hire

Dear Candidate,

Greetings from Shell Infotech!

We are pleased to share an exciting opportunity with one of our esteemed client.Please find the job description and relevant details below for your review.

premalatha@shellinfotech.com

Mode of Hire: Contract to Hire (Initially 6 months-1 Year contract with extension and direct conversion with Client-Deloitte based on your performance)

Location: Hyderabad, Bangalore, Chennai, Pune, Mumbai, Gurgaon, Kolkata

Mode of work: Hybrid-3days from Office

Total Exp:5-14 Years

Role/Skill Set:

Job Description:

Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, Digital Health, R&D systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc.

Must Have
• 2 to 6 years of experience in Computer systems validation. • Validation experience in Agile SDLC. • Working experience of tools like JIRA, HP ALM, Qtest, SAP, Solution manager, Servicenow , Valgenesis, Veeva etc. • Working experience of processes like change Management, Periodic reviews, CAPA/Deviation management.

The position provides an excellent opportunity to:

• Identify and manage regulatory risks to support client in regulatory compliance, governance and controls
  • Coordinate with cross-functional project teams for new application development and other validation projects to include reviews, risk analysis and other QA activities in support of systems development • Author validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory) • Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution and end-user training • Plan, manage and execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs) • Review and approve validation lifecycle documentation • Provide Quality review and assessment of associated change requests related to processes, IT infrastructure and computer systems.

Regards,

Prema

Email: premalatha@shellinfotech.com