Job Description

Pharma Data Integrity / Data Analysis / Data Compliance Analyst

Long term (multi-year) contract with client based in Foster City, CA


Consultant must have the following:
  1. Very good with data analysis, identifying trends and preparing metrics.
  2. Very good presentation skills - A good storyteller
  3. Need to have strong critical, analytical/ logical thinking skills.
  4. Familiar with using Office 365 suite of applications. (Powerpoint, Excel, etc.)
Job Details:
  • Perform "Data Integrity" related- risk assessments, Deviation investigations, suggest ,implement remediations in cGMP operations.

  • Able to perform Data Integrity compliance/impact assessments, risk assessments and create short executive summary reports.

  • Perform data analysis, identify trends and prepare metrics.

  • 3-5 years of experience applying global data integrity regulations to cGMP operations, computer system validation, pharmaceutical manufacturing, lab testing, supply chain process, and quality management systems.

  • 3-5 years of experience with Data Integrity risk assessments and process improvements in GxP operations.
  • Will undergo extensive training in DI.
  • We are seeking a quick learner who is willing to be hands-on for the long-term.
  • Experience in FDA regulated environment with strong understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk-based validation and 21 CFR Part 11.
  • Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter.
  • Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.
  • Must have excellent communication skills, be organized and good at multi-tasking.
Dawn West

Application Instructions

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