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Must Have Skills (Top 3 technical skills only)*:

GxP, 21 CFR Part 11, and SOX knowledge Knowledge in validation in SAP implementation is must. SDLC and GAMP knowledge

Nice to have skills (Top 2 only):

Should have worked in large programs. Able to manage direct relations with stakeholders and project team members.

Detailed Job Description:

Provide pharma regulatory compliance consulting to development projects.

Minimum years of experience*: 5+

Certifications Needed: No

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

Define and setup validation approach for GxP relevant system and to ensure that the system is validated in line with defined plan To ensure identified project methodology is followed and deliverables are produced in line with validation approach Driving achievements of the ValidationQuality goals by ensuring that the process and standards defined for the project are followed

Interview Process (Is face to face required?) No

Does this position require Visa independent candidates only? No