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Data Integrity Remediation Consultant - Boston, MA area

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ProPharma Group

Data Integrity Remediation Consultant - Boston, MA area

Boston, MA
Full Time
Paid
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  • Responsibilities

    Job Description

    Remediation and Gap Assessment of Data Integrity    A true Consulting opportunity performing Data Integrity Remediation and acting as team lead.  Providing advice and direction to the client. 

    Responsible for the Computer System Validation and Data Integrity processes of the company.

    • Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
    • Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

     

  • Qualifications

    Qualifications

     

    • Bachelor’s degree in scientific or engineering discipline along with 7 plus years of experience in the field of computer validation.
    •  Strong background (10-15 years) in GxP/biopharma processing automation systems (primarily categories 3-5 where biopharma upstream and downstream unit operation controllers (either integrated or standalone) interface with DCS/PCS or BAS/BMS).
    • Need to understand the underlying technologies from the IT infrastructure, up through the control space, then through the user operating system, and application to the end resulting record location(s).
    • Need strong background and understanding of current industry data integrity hot buttons, specifically developing data flow diagrams and being able to focus in on the weak link areas and come up with answers and results quickly.
    • Need very strong Word processing and Visio processing skills
    • Awesome communication skills. 
    • Prior performance of Plans, DI Assessments, Part 11 Assessments, Reports, SOPs/Work Instructions a MUST

    We are an equal opportunity employer. M/F/D/V

     

    Qualified candidates must be legally eligible to work for any employer in the United States.

     

    ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

     

    Additional Information

    All candidates must be legally eligible to work in the United States.

    We are an equal opportunity employer. M/F/D/V

    ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.