Job Description :
Role: Life Science IT Infrastructure Qualification Lead

Location: Foster City, CA

Mode: Contract

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.

             Leads the effort to manage, and/or maintains qualification of the GxP infrastructure components such as security devices/tools, servers, networks, data center equipment.

             Perform GxP assessment and create Qualification Plan

             Perform overall and detailed risk assessment

             Prepare and review functional and design specifications.

             Prepare and reviews validation documents such as IQ, OQ, PQ’s.

             Lead overall protocol (IQ/OQ) executions. Log and track deviations.

             Review and approval of executed protocols (IQ/OQ)

             Prepare and approve qualification summary report

             Ensure GxP Computerized Systems are in qualified/validated state as per GAMP -5/client’s requirements.

             Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.

             Maintain overall project and issue tracker and report routinely.

Desired skills / certifications / training

             10+ years in Computer System Validation, IT Infrastructure Qualification, Writing policies/procedures in Life Science domain.

             Excellent knowledge of cGMPs, , FDA and EMEA guidelines including 21 CFR Part 820, 21 CFR Part 11

             Excellent knowledge of computer system validation and GAMP -5 standards.

             Knowledge of IT security devices, tools and application

             Working knowledge of infrastructure components such as servers, networks, database and data center setups.

             Should be able to work independently. Excellent communication skills. Prior experience in working with large global teams.