IT CSV Analyst

We are seeking a detail-oriented and experienced IT CSV Analyst to support the validation of computerized systems in compliance with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other GxP standards. The role involves developing, executing, and maintaining validation documentation to ensure that systems are fit for intended use and compliant with quality standards.

Responsibilities:

Develop and maintain Computer System Validation (CSV) documentation including:

Validation Plans (VP).

User Requirements Specifications (URS).

Functional Specifications (FS).

Risk Assessments.

Test Plans, IQ/OQ/PQ Protocols.

Traceability Matrices.

Validation Summary Reports (VSR).

Work closely with IT, QA, business stakeholders, and vendors to ensure compliance with regulatory and internal requirements.

Review and assess change controls, deviations, and CAPAs related to computerized systems.

Ensure systems are developed and maintained in accordance with GAMP 5 guidelines.

Support audits and inspections by regulatory authorities and clients.

Participating in system implementation projects, ensuring validation activities are integrated into the project lifecycle.

Maintain documentation and validation lifecycle in alignment with data integrity principles (ALCOA+).

Conduct periodic reviews of validated systems to ensure ongoing compliance. Requirements:

Bachelor's degree in computer science, Information Technology, Life Sciences, or related field.

Minimum 3-5 years of experience in IT CSV, QA, or compliance roles in a regulated environment (pharma, biotech, or medical devices).

Strong knowledge of GxP regulations, including 21 CFR Part 11, EU Annex 11, and GAMP 5.

Familiarity with SDLC (Software Development Life Cycle) and validation in Agile/Waterfall methodologies.

Experience with ERP, LIMS, MES, Track Wise, or other GxP-regulated systems is a plus.

Strong documentation, analytical, and communication skills.

Ability to work independently and in cross-functional teams.

Experience with validation tools or eQMS systems (e.g., Veeva, Master Control, Kneat).

Knowledge of cloud-based validation and SaaS compliance.

Understanding data integrity and cybersecurity principles in a regulated environment.