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Senior Data Integrity Consultant

Dawar Consulting

San Diego, California

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Computer Science, Computer Systems, Consulting, Data Quality, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Gene Therapy, Laboratory Systems, Maintain Compliance, Manufacturing, Manufacturing Software, Manufacturing Systems, Process Validation, QA Partner Testing Software, Quality Control, Risk Analysis, System Validation, Validation Documentation
LOCATION
San Diego, California
POSTED
13 days ago
Our client, a world leader in biotechnology and life sciences, is looking for a “Senior Data Integrity Consultant<\/b>” based out of San Diego, CA<\/b>.
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Job Duration:<\/b> Long Term Contract (Possibility Of Extension)
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Pay Rate:<\/b> $85/hr - $92/hr on W2 DOE
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Company Benefits:<\/b> Medical, Dental, Vision, Paid Sick leave, 401K
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Summary<\/b>
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In this role, you will support Data Integrity (DI) and Computer System Validation (CSV) activities within a GMP -regulated biotech environment. And, you will provide Quality oversight for computerized systems, laboratory systems, manufacturing applications, and paper -based processes to ensure compliance with FDA and EU regulatory requirements.
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Responsibilities<\/b>
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  • Lead Data Integrity governance and compliance activities
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  • Perform gap assessments, risk assessments, and remediation support
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  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles
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  • Review and support CSV deliverables including URS, IQ/OQ/PQ, risk assessments, and validation documentation
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  • Support audit readiness, periodic reviews, user access reviews, and change controls
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  • Partner with QA, QC, Manufacturing, Validation, and IT teams on GMP compliance initiatives
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    Qualifications<\/b>
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    • Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
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    • 8+ years of GxP experience in pharmaceutical or biotech environments
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    • Strong experience in:
      Data Integrity
      Computer System Validation (CSV)
      GMP Quality Compliance
      Laboratory and Manufacturing Systems
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    • Strong knowledge of: FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ principles<\/span><\/span><\/span>
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    • Preferred experience in biotech, cell/gene therapy, or GMP manufacturing environments.<\/span><\/span>
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      If interested, please send us your updated resume at

      hr@dawarconsulting.com

      lakshmi@dawarconsulting.com

About the Company

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Dawar Consulting

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