System Specialist

2 weeks ago

Nashik, Maharashtra, India beBeeComputerSystemValidation Full time ₹ 9,00,000 - ₹ 21,00,000

We are seeking a highly skilled Computer Systems Professional to join our team as a System Specialist.

About the Role

The successful candidate will be responsible for ensuring data platform applications are validated and meet industry standards. They will have experience in Agile methodology and managed multiple releases in parallel.

Key Responsibilities
  • Develop extensive knowledge in CSV auditing, creation, and revision of CSV documentation.
  • Manage Data Platform applications project management, test script review, test execution review, and test defect management.
  • Guide project teams with applicable project deliverables based on project type and category while catering to the Software Development Life Cycle (SDLC).
  • Apply FDA guidance's and industry standards (i.e., GAMP) for computer system validation.
  • Have a strong understanding of 21 CFR Part 11 and Risk-Based Approach to guide project teams.
  • Draft and approve CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report.
  • Familiarize yourself with procedures, work instructions, forms, and templates.
  • Show a solid understanding of SDLC, Jira, QTest, automated test tools, code repository like Bitbucket, and change control/management systems like ServiceNow.
Required Skills

1. Computer System Validation

2. Test Case Review, Validation Plan, Validation Summary Report

3. 21 CFR part 11

4. Validating SAP, ERP, LIMS, Data Platforms

5. GAMP Guidelines, GxP Guidelines, Industry Standards

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