MiamiRecruiter Since 2001
the smart solution for Miami jobs

QMS/ GMP Consultant

Company: MMS
Location: Miami
Posted on: May 26, 2023

Job Description:

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in -Global Health & Pharma's -international awards programs for the last three consecutive years. For more information, visit - -or follow MMS on -.This role is a project-based consulting opportunity.Responsibilities:

  • Establish or maintain record management for a GMP facility
  • Computer Software Validations/ eQMS implementation:
    • Experience implementing eQMS systems
    • Create computer validation plans
    • Assist in testing of systems
    • Create procedures for users, maintenance, and security of systems
    • Establish or maintain GMP/ QMS training for a GMP facility
    • Create controlled documents for compliance with a quality system
      • Batch record review and/or release, including ensuring process controls are met for a production run, reviewing all documents related to the lot, and working with client to address any items found prior to release of the lot
      • Assist in the qualification of suppliers for use for a GMP facility including preparing Evaluation questionnaire, Quality Agreements, and supplier tracking, as needed.
      • Experience with interacting with regulatory authorities during a Health Authority Inspections
      • Experience with performing investigation, Correction plans, and preparing response to regulatory authority observations.
      • Experience with performing error investigations of procedural errors, customer complaints, or non-conforming material.
      • Experience creating CAPA plans and performing risk assessments
      • Experience planning, executing, and reporting of method, process, or equipment validationsRequirements:
        • 10 years of experience in a GMP/ QMS role within the CRO, Pharma, or Biotech industry
        • Bachelors Degree in a scientific, medical or clinical discipline
        • Expert knowledge of scientific principles and concepts
        • Proficiency with MS Office applications
        • Hands-on experience with clinical trial and pharmaceutical development preferred - - - - - - - - - - - - - -
        • Good communication skills and willingness to work with others to clearly understand needs and solve problems
        • Excellent problem-solving skills
        • Good organizational and communication skills
        • Familiarity with current ISO 9001 and ISO 27001 standards preferred
        • Familiarity with 21 CFR Part 11, FDA, and GCP requirements
        • Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development processPowered by JazzHR

Keywords: MMS, Miami , QMS/ GMP Consultant, Professions , Miami, Florida

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Florida jobs by following @recnetFL on Twitter!

Miami RSS job feeds