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Data Integrity / Validation Analyst Consultant

Foster City, Ca · Biotech/Pharmaceutical
Title: Data Integrity / Validation Analyst
Type of role: Contract 12++ months
Location: Foster City, CA 94404 (*Remote during COVID)

Job Description:
  • Perform “Data Integrity” risk assessments, Deviation investigations, write summary reports, suggest remediations in cGMP operations. For this, a consultant need to have an understanding of current global regulatory expectations around data integrity, computer system validation, pharmaceutical manufacturing, lab testing, supply chain process, and quality management systems.
  • Able to create data process maps and perform risk assessments (failure mode analysis).
  • Able to perform compliance gap assessments, risk assessments and create summary reports.
Qualifications:
  • Candidate must have experience with Data Integrity related assessments and process improvements in GxP operations. 
  • Good with systems analysis, excellent oral and written communication skills.
  • Highly determined.
  • Ability to think through the task
  • Fast learner with multiple technologies used in cGMP operations
  • Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies.
  • Extensive Knowledge of applying 21CFR Part11, 211, Annex 11, and industry best practices into operations.
  • Need to have strong critical/analytical/logical thinking skills.
  • Need to have good presentation skills. (A good storyteller)
  • Ability to work independently without supervision.
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