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Data Integrity Project Lead

VTI Life Sciences (VTI) is a highly successful, growing Biopharmaceutical consulting company.  We are currently seeking a strong Mid-level Quality Validation Engineer to lead a data integrity assessment project.  You will develop methodology to determine data integrity gaps for QC lab instruments and manufacturing equipment including associated software and systems for our client in the Fremont, CA area

VTI strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Lifesciences industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.  We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

REQUIREMENTS;

  • Lead a data integrity assessment project.                                                                                              
  • Develop methodology to determine data integrity gaps for QC lab instruments and manufacturing equipment including associated software and systems. 

EXPERIENCE:

  • Strong experience creating assessments
  • Experience validating software related to analytical instruments and manufacturing equipment and creating CAPAs.
  • Excellent written and verbal communication skills.
  • Knowledge of USP 1058, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity.

 

VTI Life Sciences Offers:

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices.  We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors.  www.validation.org

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