Software QA/Test (Expert)-App & Platform Mgmt-IT-C

Location: Berkeley, CA Description: Our client is currently seeking a Validation Specialist - Analytical Instrument Qualification/Software Validation POSITION SUMMARYPerform analytical computerized instrument and software validation, spreadsheet validation and validation periodic review to support a variety of the labs within QC organization.Education Requirement(s):

• Bachelor's Degree in Science or Engineering

• 5-6 years of experience in pharmaceutical or related industry or an equivalent combination of education and experience.
• 2+ years' experience in performing analytical computerized instrument and software
• validation.
• Strong understanding of cGMP, 21 CFR Part 11, global regulatory compliance.
• Strong technical/business writing and communication skills.
• Knowledge in risk assessment, gap analysis, changes control and deviation management.
• Strong computer skills, including Word, Excel, PowerPoint and databases.
• Strong understanding of Empower.
• Must be able to demonstrate knowledge of validation principles, including user
• requirements, system specifications, IQ, OQ, and PQ.
• Ability and initiative to work with minimal supervision required.
• Strong ability to plan and prioritize complex and conflicting objectives to meet release goal.
• Excellent organizational skills, capable of multi-tasking and creating validation/qualification documents for multiple projects simultaneously.