What are the responsibilities and job description for the GCP Consultant position at MMS?
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 inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years. For more information, visitwww.mmsholdings.comor follow MMS onLinkedIn.
This role is a project-based consulting opportunity.
Responsibilities:
- Assist in vendor qualification of CROs, including preparing evaluation, quality agreements
- Vendor oversight and monitoring, as needed
- Experience with performing investigations of errors investigations and risk assessments
- Create controlled documents for compliance to regulatory requirements of the study planning, performance, final reporting
- Computer Software Validations/ eQMS implementation
- Implementation of eQMS systems including creating computer validation plans, assisting in testing of the system, and creating procedures for users, maintenance, and security of the system
- Experience with hosting and interacting with regulatory authorities during an inspection
Requirements:
- 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 process
