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1. Validation
2. Compliance
3. GxP

Detailed Job Description:

• Exposure in Life Science industry as a Validation Analyst.
• Support project managers on the application of the project methodology and ensure that project follows the process in compliance with GAMP5, 21 CFR Part 11 and GxP norms and other applicable regulations.
• Understand and adhere to the SOPs on Document Management, Quality Management, Computerized System Validation (CSV) concept and the document management.
• Create/review high level compliance deliverables Create Validation Plan, Data Migration Plan, GxP risk Assessment, reviewing the specifications and Testing documents for GDP (Good documentation Practices)
• Record project - originated GxP deviations where applicable
• Reviewing and managing testing deviations from compliance perspective.

Minimum years of experience*: 5+

Certifications Needed: No

Top 3 responsibilities you would expect the Subcon to shoulder and execute*:

1. Validation
2. Compliance
3. GxP

Interview Process (Is face to face required?) No

Does this position require Visa independent candidates only? No