Job Description :
Job Title: Validation Lead
Location: Foster City, CA
Duration: Long Terms Contract

Job Description:
This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for IT Infrastructure Services. This position is also responsible for monitoring Computer System validation (CSV), Infrastructure Qualification activities as well as compliance with 21 CFR Part 820 and 21 CFR Part 11.
1. Leads the effort to manage, and/or maintains qualification of the GxP infrastructure components such as security devices/tools, servers, networks, data center equipment.
2. Perform GxP assessment and create Qualification Plan
3. Perform overall and detailed risk assessment
4. Prepare and review functional and design specifications.
5. Prepare and reviews validation documents such as IQ, OQ, PQ’s.
6. Lead overall protocol (IQ/OQ) executions. Log and track deviations.
7. Review and approval of executed protocols (IQ/OQ)
8. Prepare and approve qualification summary report
9. Ensure GxP Computerized Systems are in qualified/validated state as per GAMP -5/client’s requirements.
10. Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
11. Maintain overall project and issue tracker and report routinely.

Desired skills / certifications / training
1. 10+ years in Computer System Validation, IT Infrastructure Qualification, Writing policies/procedures in Life Science domain.
2. Excellent knowledge of cGMPs, , FDA and EMEA guidelines including 21 CFR Part 820, 21 CFR Part 11
3. Excellent knowledge of computer system validation and GAMP -5 standards.
4. Knowledge of IT security devices, tools and application
5. Working knowledge of infrastructure components such as servers, networks, database and data center setups.
6. Should be able to work independently. Excellent communication skills. Prior experience in working with large global teams.