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Data Integrity Lab Remediation Consultant

P

ProPharma Group

Data Integrity Lab Remediation Consultant

Irvine, CA
Full Time
Paid
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  • Responsibilities

    Job Description

     Perform CSV remediation for laboratory instrument, manufacturing automation, and IT Infrastructure laboratory instrument / software validation and support such as Waters and Agilent HPLC systems, Waters Empower CDS, FTIR Agilent (MicroLab) ChemStation software, UV-VIS, AA, TOC, plate reader. Create and develop SOPs, validation templates. 

    • Technology refresh to replace non-compliant older equipment and software with the latest systems allowing for state-of-the-art control and audit trail (ie. a new LIMS, new software for spectrophotometers, new software for secure data collection from Metler Toledo instruments: balances, titrators (Karl Fisher) and pH meters FTIR (Agilen Technologies MicroLab and Cary WinUV, Charles River Cortex (for Endosafe instruments) as well as connection of instruments to network servers and/or the new LIMS. - 

    • Experience in QC Analytical Lab systems. -experience in CSV DI Lab remediation for laboratory instrument, manufacturing automation, and IT Infrastructure laboratory instrument / software validation and support such as Waters and Agilent HPLC systems, Waters Empower CDS, FTIR Agilent (MicroLab) ChemStation software, UV-VIS, AA, TOC, plate reader. - extensive experience with 21 CFR Part 11 (and Annex 11), principles of data integrity and ALCOA+, and US FDA’s ata Integrity and Compliance with CGMP - Create and develop SOPs, validation templates. 

    • Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment - Experience with Lab Systems preferable - Lab Experience is a plus - Experiences with systems from Metler Toledo, Agilent, Perkin Elmer, Shimadzu preferable - Experience with quality assurance standards such as ISO, ICH, USP & GxP is preferred. - CGMP’s, QSR’s, ISO, CMDR, and MDD

    • Responsible for the Computer System Validation 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.
    • Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply.

     

  • Qualifications

    Qualifications

     

    • Bachelor’s degree in scientific or engineering discipline along with 7 plus years of experience in the field of computer validation.

    • Ideal candidate will have a Laboratory Systems Background (LIMS) and Laboratory Equipment (HPLC, GC, AA). Previous experience working with higher level systems including: Trackwise and ERP.

    • Previous automation experience (preferred).

    • Considered a Subject Matter Expert (SME) in terms of qualification for at least one type of system. Individual will work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

    • Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.

    • Candidates must have excellent verbal communication and technical writing skills.

    • Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).

    • Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.

    • Experience in Project execution within at least one area of systems validation – e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems.

    • Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.

    • Ability to plan and manage own work

    • Must be willing to travel regionally and/or nationally throughout the US.

     

     

    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.