Foster City Foster City, CA 94065
Job Title: Qualification Lead
Location: Foster City, CA - 94065
Duration: 6+ Months Contract
About our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
Essential Duties and Responsibilities:
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.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities.
Vincent Gandra @ firstname.lastname@example.org - 415-200-4129