1.2 Ensure that validation and quality assurance processes are aligned with industry regulations such as FDA's 21 CFR Part 11, GxP, or other relevant frameworks.

2. CSV and CSA Execution:

2.1 Oversee and conduct Computer System Validation (CSV) and Computer Software Assurance (CSA) processes to ensure compliance with regulatory requirements.

2.2 Maintain validation documentation, including IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) protocols.

3. Risk Management:

3.1 Participate in risk assessments related to software and system changes to evaluate potential impacts on compliance and product quality.

3.2 Develop and implement risk mitigation strategies to address identified risks.

4. Documentation and Reporting:

4.1 Compile and manage validation documentation, including traceability matrices, validation plans, and reports.

4.2 Prepare and deliver presentations on validation activities and compliance status to stakeholders.

5. Collaboration:

5.1 Provide training and guidance to other staff on CSV and CSA methodologies and best practices.

6. Qualification :

6.1 A degree in Computer Science, Information Technology, Engineering, or a related field is typically required.

7. Experience:

7.1 Experience in IT_QA roles within regulated industries, focusing on CSV and CSA processes.

8. Regulatory Knowledge:

-8.1 Strong understanding of regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, and other compliance standards

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Junior Manager