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Posted 3 months ago

Software Validation Engineer (FULL ENGLISH SPEAKING)

Details

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Not disclosed
Compensation
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Full time
Time commitment
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Outsourcing/Offshoring
Industry
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Between 51 - 200
Company size

Skills

Software Validation
Bachelors Degree > Bachelors Degree Information Technology
Fluent In English Both Oral And Written
Bachelors Degree > Bachelors Degree Computer Science

Job description

RESPONSIBILITIES:
  • Define, design, implement the validation documents and review and sign the Verification, Validation Protocols and Reports (Validation Plan, Functional Requirement Document, Operational Qualification, Performance Qualification, RTM and Validation Summary report).
  • Use Software development Lifecyle methodology for Risk based approach to software validation.
  • Maintain Standard Operating procedures for the day-to-day maintenance of the applications and underlying systems.
  • Consult, Support customer in software validation process for validating the systems.
  • Establish clear communication channels and ensure proper feedback mechanisms are in place with customers, peers, and cross functional teams.
  • Ensure proper retention polices of executed validation documents are in place to ensure systems are validated
  • Propose system enhancements (software and hardware updates) that will improve the performance and reliability of the system.
  • Maintain and update End to End Process interpretation and understanding to , update and release and run Software Validation task and activities.
  • Software Quality reviews and systems audits
  • Software compliance and Gap assessments
  • Software Quality Assurance
Skills and Experience:
  • Bachelors of Science in Information Technology, Computer Science, OR Equivalent work experience
  • 5+ years of experience with regulatory industry software validation.
  • Must have knowledge of IT environments and how to maintain applications
  • Must have in-depth knowledge of Computer System Validation, FDA Part 11 and Part 820 regulations, GAMP 5, ERES
  • Outstanding oral and written communication skills with a high attention to detail.
Eterna Indonesia is an offshoring company with clients in the United States of America. We work with renewable energy and tech companies.
Our company started in February 2021. The team consists of fresh, young, and thriving individuals, excited to help the world become a better place, transitioning into a greener and more sustainable world. We are looking for motivated individuals eager for growth. We provide the opportunity to expand your skillset from a global scale.
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