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Validation Specialist

India, Republic Of India, Bengaluru
Last update 2025-02-07
Expires 2025-02-06
ID #2566589559
Free
Validation Specialist
India, Republic Of India, Bengaluru,
Modified January 24, 2025

Description

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.

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Validation specialist

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