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Sr Data Integrity Supervisor / Pharma Compliance Specialist

Foster City, CA · Biotech/Pharmaceutical
Sr Data Integrity Supervisor / Pharma Compliance Specialist

Location: South San Francisco, CA (Remote)
Type of role: Contract
Duration: 1-2 years or longer

***Covid Remote 

We are looking for a senior level consultant to help with the Data Integrity program for our Pharma client in Foster City, CA. Need someone with strong regulatory compliance, CSV and Data Integrity background. (This is an advisory and a hands-on role).
 
Below is an overview of responsibilities:
  • Perform “Data” risk assessments, Deviation investigations, write summary reports, suggest remediations in cGMP operations. For this, a consultant need to have an understanding of current regulatory expectations, computer system validation, pharmaceutical manufacturing, lab testing, supply chain process, and quality management systems.
  • Able to create various types of (business, data) process maps for risk assessments.
  • Able to perform compliance gap assessments, risk assessments. Need to have strong critical/analytical/logical thinking skills.
  • Need to have good presentation skills. (A good storyteller)
  • Supervisory and mentoring skills 
Note: This role requires more of a compliance background than an IT background.
 

 
 
Dawn West
AdeptSource
 

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