Quality Assurance Analyst - IT Compliance & CSV

Key Responsibilities :

- Create, review, and maintain SOPs, Policies, Guidelines, and Procedures related to quality assurance.

- Perform internal audits and assist in preparing for and facing external audits (regulatory or client).

- Ensure compliance with 21 CFR Part 11, EU Annex 11, GDPR, and other relevant global regulations.

- Lead investigations and manage documentation for Deviations and CAPAs.

- Support IT GxP system compliance, ensuring systems are validated and maintained per

regulatory expectations.

- Contribute to and support Computer System Validation (CSV) activities and documentation.

- Provide oversight and support on Data Privacy and Data Security practices in IT systems.

- Support ISO 27001 implementation and audits, including maintaining documentation and process adherence.

- Ensure continuous improvement of quality processes and help maintain a robust quality management system (QMS).

Required Skills & Qualifications :

- Bachelors degree in Life Sciences, Computer Science, or a related field.

- 3 - 4 years of experience in a QA role within a regulated environment.

- Solid understanding of GAMP 5, CSV, and GxP practices.

- Familiarity with data privacy regulations (e.g., GDPR).

- Working knowledge of ISO 27001, 21 CFR Part 11, and EU Annex 11.

- Experience in writing and handling Deviations, CAPAs, and participating in audit processes.

- Excellent documentation, communication, and stakeholder management skills.

- Strong attention to detail and analytical skills.