Job Summary:
We are seeking a highly skilled and experienced Validation Specialist to lead and execute the Computer Systems Validation (CSV) activities for IT systems used in pharmaceutical manufacturing environments.
Key Responsibilities
1. Validation Documentation:
*Author comprehensive Validation Plans, Test Plans, and Requirements Specifications.
*Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts.
*Prepare and review detailed Test Execution, Test Reports, and Validation Reports.
2. System Validation and Deployment:
*Oversee global and local deployments of manufacturing IT systems, ensuring compliance with regulatory guidelines (e. G., FDA, EMA, Gx P).
*Support system validation for new implementations, upgrades, and system modifications.
3. Compliance Management:
*Ensure all IT systems comply with applicable regulations, standards, and internal policies.
*Drive effective change management and handle deviation management processes.
4. Testing and Quality Assurance:
*Collaborate with cross-functional teams to execute rigorous system testing and validation activities.
*Ensure traceability between requirements, test cases, and executed results.
5. Agile Practices (Preferred):
*Contribute to Agile methodologies and practices, supporting iterative system development and validation.
6. Stakeholder Engagement:
*Work closely with project teams, Quality Assurance, IT, and Manufacturing teams to ensure smooth project execution.
*Communicate effectively to report progress, issues, and compliance metrics.
Role Requirements and Qualifications:
*Minimum 5 years of experience in CSV within the pharmaceutical industry.
*Proficient in authoring validation deliverables, including Validation Plans, Test Scripts (IQ, OQ, PQ), and Reports.
*Experienced with global and local deployments of manufacturing systems.
*Experience working in Agile environments or familiarity with Agile methodologies.