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Data Integrity and Computer System Validation Consultant

San Mateo, CA
Title: Computer System Validation and Data Integrity Consultant
Type/ Location: Contract/ San Mateo, CA
Overview:
We are looking for a Computer System Validation and Data Integrity Consultant for a Life Sciences client at San Mateo. The position will work on driving Data Integrity policies, principles, and collaborating with CMOs and other business. 
Also, the person will work with pharmaceutical partners and platform providers to facilitate the development of remediation plans, training, and support the execution of the plan.
Deliverables and Responsibilities:
  • Design, perform Data Integrity risk assessments, write reports, suggest remediation’s in CGMP operations by having an understanding of computer system validation, pharmaceutical manufacturing, testing, supply chain process.
  • Weekly monitoring of evolving regulations, FDA warning letters, 483’s related to Data integrity, prepare trend reports to stay current with “c”GMP regulations with the understanding of where they can find this information, analyze and prepare executive summary reports.
  • Prepare metrics relevant to evolving citations and being familiar with analytics tools like a spreadsheet, Microsoft powerBI, Tableau will help us focus on the trends and associated insights.
Requirements:
  • 10-15 years of experience with Data Integrity programs (develop new approaches, assessments, suggest remediation’s/solutions in cGMP operations preferred with pharmaceutical background)
  • Good understanding of computer system validation and management in cGMP operations.
  • Strong at analytics (analysis of agency-related warning letters, 483s, pattern recognition, prepare intelligence reports, metrics )
  • Highly determined
  • Ability to think through the task.
  • Fast learner with evolving technologies.

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