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We have Immediate requirement for below position

1. Documentation Support

  • Preparing and reviewing validation documentation such as Validation Master Plan (VMP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and System Design Specifications (SDS).
  • Preparation of validation protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Maintain records of executed protocols and test results.

2. Testing and Execution

  • Knowledge in executing validation protocols.
  • Perform basic functional testing of systems to verify compliance with requirements.
  • Record and document test results accurately
  • Support root cause analysis and troubleshooting.

3. Regulatory Compliance

  • Familiarize with regulatory guidelines like FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards.
  • Ensure validation activities align with these regulatory requirements.

4. Training and Awareness

  • Capable to take training sessions on processes, quality standards, and validation procedures.
  • Support training for end-users on validated systems.

5. Change Control Support

  • Knowledge on change control processes, ensuring proper documentation and re-validation where required.
  • Assist in impact assessments for changes in validated systems.

6. Audit Support

  • Internal and external audits.
  • Ensure validation documentation is complete and audit-ready.

7. Risk Management

  • Assist in risk assessments related to computer systems.
  • Document risk mitigation strategies and support their implementation.

8. Communication and Collaboration

  • Collaborate with cross-functional teams, including IT, Quality Assurance (QA), and Operations.
  • Update senior validation professionals on task progress and issues encountered.
  • Collaborate with IT teams for system configuration, software installations, and user access management.

9. Periodic Review

  • Participate in periodic reviews of validated systems to ensure continued compliance.
  • Identify systems requiring re-validation due to changes or updates.

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