Job Summary
Overview of the Role
As a CSV Specialist in the pharmaceutical sector, you will play a pivotal role in ensuring compliance of computer systems with regulatory requirements, supporting the company’s mission to deliver safe and effective healthcare products. Your expertise will safeguard data integrity and system reliability, directly impacting regulatory submissions, product quality, and business continuity. You will collaborate with cross-functional teams, providing validation leadership that supports both operational excellence and innovation.
Detailed Responsibilities
- Develop, execute, and maintain Computer System Validation (CSV) protocols (IQ, OQ, PQ) for GxP-regulated systems in line with FDA, EMA, and global regulatory guidelines.
- Author and review validation deliverables such as risk assessments, validation plans, traceability matrices, and summary reports.
- Collaborate with IT, Quality Assurance, and business stakeholders to define user requirements, ensure data integrity, and manage validation lifecycle documentation.
- Conduct periodic reviews, system impact assessments, and change control evaluations for validated systems.
- Support audits and inspections by regulatory authorities, preparing and presenting validation evidence as required.
- Provide subject matter expertise on 21 CFR Part 11, Annex 11, and relevant industry standards, ensuring systems adhere to compliance and security best practices.
- Train and mentor end-users and junior team members on validation processes and SOPs.
- Drive continuous improvement initiatives to optimize validation strategies and enhance regulatory compliance.
Skill Requirements
- Bachelor’s or Master’s degree in Computer Science, Life Sciences, Engineering, or a related field.
- 3+ years of hands-on experience in Computer System Validation within the pharmaceutical or life sciences industry.
- In-depth knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and global CSV standards.
- Strong analytical, documentation, and project management skills.
- Proficiency in developing validation documentation, test scripts, and risk assessments.
- Excellent verbal and written communication skills.
- Experience working with electronic systems such as LIMS, ERP, MES, or similar platforms.
Key Responsibilities
Overview of the Role
As a CSV Specialist in the pharmaceutical sector, you will play a pivotal role in ensuring compliance of computer systems with regulatory requirements, supporting the company’s mission to deliver safe and effective healthcare products. Your expertise will safeguard data integrity and system reliability, directly impacting regulatory submissions, product quality, and business continuity. You will collaborate with cross-functional teams, providing validation leadership that supports both operational excellence and innovation.
Detailed Responsibilities
- Develop, execute, and maintain Computer System Validation (CSV) protocols (IQ, OQ, PQ) for GxP-regulated systems in line with FDA, EMA, and global regulatory guidelines.
- Author and review validation deliverables such as risk assessments, validation plans, traceability matrices, and summary reports.
- Collaborate with IT, Quality Assurance, and business stakeholders to define user requirements, ensure data integrity, and manage validation lifecycle documentation.
- Conduct periodic reviews, system impact assessments, and change control evaluations for validated systems.
- Support audits and inspections by regulatory authorities, preparing and presenting validation evidence as required.
- Provide subject matter expertise on 21 CFR Part 11, Annex 11, and relevant industry standards, ensuring systems adhere to compliance and security best practices.
- Train and mentor end-users and junior team members on validation processes and SOPs.
- Drive continuous improvement initiatives to optimize validation strategies and enhance regulatory compliance.
Skill Requirements
- Bachelor’s or Master’s degree in Computer Science, Life Sciences, Engineering, or a related field.
- 3+ years of hands-on experience in Computer System Validation within the pharmaceutical or life sciences industry.
- In-depth knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and global CSV standards.
- Strong analytical, documentation, and project management skills.
- Proficiency in developing validation documentation, test scripts, and risk assessments.
- Excellent verbal and written communication skills.
- Experience working with electronic systems such as LIMS, ERP, MES, or similar platforms.