SpurQLabs | Next-Generation Software Testing
3 weeks ago
The CSV (Computer System Validation) Validation Specialist is responsible for leading and executing the validation lifecycle of computerized systems within the pharmaceutical industry, ensuring compliance with FDA, GMP, GLP, and 21 CFR Part 11 requirements. This role focuses on delivering key validation documents and managing the complete validation process, including system requirements, risk assessments, change control, and maintaining regulatory compliance. The specialist will collaborate with cross-functional teams to ensure that all computerized systems meet validation standards.
Key Responsibilities:
Computer System Validation (CSV):
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.
Qualifications:
Education:
Bachelor’s degree in Computer Science, Engineering, Biotechnology, Life Sciences, or a related technical field.
Experience:
Minimum of 10-12 years of experience in CSV validation within the pharmaceutical, medical device, or biotech industry.
Extensive experience in preparing and executing validation deliverables including Validation Plans, IQ/OQ/PQ protocols, and Validation Summary Reports.
Knowledge of regulatory guidelines and compliance standards such as FDA, GMP, GLP, and 21 CFR Part 11.
Proven experience with various computerized systems used in laboratories and production environments.
Skills:
Strong knowledge of validation lifecycle management and key validation deliverables.
Expertise in preparing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Strong technical writing skills, with the ability to document validation protocols, test results, and summary reports.
Proficiency in managing change control and risk management processes.
Excellent communication and problem-solving skills.
Proficient in Microsoft Office, validation software tools, and other relevant applications.
Additional Requirements:
Ability to work in a highly regulated environment and meet strict timelines.
Strong collaboration skills, with experience working across multiple departments.
Flexibility to adapt to changing project priorities and regulatory updates.
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