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