Computer System Validation Specialist

1 week ago

Vadodara, Gujarat, India SpurQLabs | Next-Generation Software Testing & Test Automation Services Full time

SpurQLabs is a cutting-edge software testing and test automation company dedicated to empowering our clients with exceptional quality products at unparalleled speed.

We offer a comprehensive range of services in test automation, API testing, performance testing, and CI/CD. Our team envisions delivering the most reliable, secure, scalable, and user-friendly software solutions in efficient and cost-effective ways to end-users.

The CSV (Computer System Validation) Validation Specialist plays a pivotal role in leading and executing the validation lifecycle of computerized systems within the pharmaceutical industry, ensuring compliance with FDA, GMP, GLP, and 21 CFR Part 11 regulations.

This specialist will be responsible for delivering key validation documents and managing the complete validation process, including system requirements, risk assessments, change control, and maintaining regulatory compliance.

The ideal candidate will collaborate with cross-functional teams to ensure that all computerized systems meet validation standards.

Key Responsibilities:
  • Lead validation activities for computerized systems, ensuring compliance with FDA, GMP, GLP, and 21 CFR Part 11 regulations.
  • Perform validation tasks across various systems
  • Ensure the development and execution of the following key deliverables:

Validation Plan: Develop and maintain a comprehensive validation plan that outlines the scope, objectives, and approach for the validation activities.

System Requirements Specification (SRS): Document system functional and operational requirements to ensure the system's compliance with regulatory standards.

Requirements Traceability Matrix (RTM): Ensure all system requirements are met and mapped to the appropriate testing and qualification protocols.

Software Installation Documentation (IQ): Develop and execute installation qualification (IQ) protocols to confirm proper installation of computerized systems.

Operational Qualification (OQ) Protocol: Design and document OQ protocols to verify the system's operational functionality in alignment with specified requirements.

Executed Operational Qualification Test: Ensure accurate execution and documentation of operational qualification testing to confirm that systems function as intended.

Performance Qualification (PQ) Scripts: Develop and implement performance qualification (PQ) scripts to test the system under simulated operational conditions.

Executed Performance Qualification: Ensure the performance qualification testing is completed, documented, and meets operational and performance requirements.

Validation Summary Report: Compile validation activities and results into a comprehensive validation summary report, providing a final assessment of the system's compliance and fitness for use.

Change Control & Risk Management:
  • Oversee change control processes for system updates or modifications, ensuring thorough risk assessments and impact analyses for any system changes.
  • Document and execute change controls related to system validations, ensuring compliance with the latest regulatory guidelines.
Documentation and Compliance:
  • Develop and maintain detailed validation protocols, test scripts, traceability matrices, and validation summary reports for all computerized systems.
  • Ensure compliance with FDA, GMP, GLP, and 21 CFR Part 11 regulations, maintaining a thorough audit trail of all validation activities.
  • Participate in internal and external audits, providing detailed validation documentation and ensuring systems meet regulatory requirements.
Cross-Functional Collaboration:
  • Work closely with IT, production, quality assurance, and engineering teams to ensure CSV requirements are met throughout the system's lifecycle.
  • Provide technical guidance and troubleshooting support for CSV-related issues and ensure efficient resolution of any validation roadblocks.
Continuous Improvement:
  • Review and improve validation processes to enhance efficiency, compliance, and alignment with evolving regulatory requirements.
  • Stay current with the latest regulatory standards, industry trends, and best practices in CSV.

Estimated Salary: $120,000 - $150,000 per year, depending on experience and qualifications. We offer a competitive compensation package, benefits, and opportunities for growth and professional development in a dynamic and innovative work environment.

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