Computer System Specialist

4 weeks ago

Bengaluru, Karnataka, India HCLTech Full time

Greetings from HCL Technologies

Hiring for "Computer system validation"

Experience - 4 to 20 years

Location - Bangalore / Chennai / Hyderabad / Noida / Pune

Notice Period -Immediate to 90 days

CTC- Open for discussion

About the Role

Experience in Computer System Validation of Data platform applications like Data lake, Data Warehouse, Data Bricks etc. Must have experience in Agile methodology and handled multiple releases in parallel.

Responsibilities

  • Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation.
  • Experience with Data Platform applications project management, test script review, test execution review, test defect management.
  • Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.
  • Application of FDA guidance's and industry standards (i.e., GAMP).
  • Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
  • Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report.
  • Must be familiar with procedures, work instructions, forms and templates.
  • 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

Interested candidates please drop mail to " "

Regards,

Kushma

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