Description
We are looking for a Validation Consultant - Identity & Access Management System in CA
Job Location: Foster City, CA
Number of positions: 1
Star Date: ASAP
Duration: 6 months+
- Validation-Identity & Access Mgmt. system
- Minimum 10 years information technology and/or pharmaceutical industry experience with exposure to a broad range of GxP validation activities
- such as document control, computer systems, vendor assessment, and change control.
- 5 years experience performing testing and system validation work in a cGMP environment
- Must possess excellent technical writing, documentation and communication skills
- Must have experience qualifying/validating an Identity and Access Management system and some level of technical understanding of such architecture.
- Familiarity with FDA requirements for computerized systems, including 21 CFR Part 11 as well as GAMP guidance documents
- Strong attention to detail, quality oriented
- Develop validation strategy for GxP projects, including resource requirements and schedule.
- Lead and document computerized system risk assessments.
- Create and/or review validation documentation such as Validation Plan, URS, Functional Requirements, Design Documents, IQ/OQ/PQ and associated test scripts, and Validation Summary Packages.
- Review computer system change requests and perform impact assessments.
- Participate in issue investigation and associated CAPA identification, management, and resolution.
- Identify exceptions associated with validation protocol execution and system maintenance and follow issue resolution procedures.
- Please send in your updated Resume in Word format along with rate expected/hour, contact details and availability status.