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GCP Auditing Consultant - Remote

Remote: 
Full Remote
Contract: 
Full time
Salary: 
10 - 10K yearly
Experience: 
Senior (5-10 years)
Work from: 
Australia

Offer summary

Qualifications:

Minimum 5 years GCP auditing experience, Bachelor’s Degree in relevant discipline, Proficiency with MS Office applications.

Key responsabilities:

  • Independently conduct vendor and site audits
  • Vendor oversight and monitoring as needed
  • Experience with investigations and regulatory interactions
MMS logo
MMS SME https://www.mmsholdings.com
501 - 1000 Employees
About MMS
MMS is an award-winning, global clinical research organization (CRO) that supports leading pharmaceutical and biotech companies as well as many smaller enterprises across our spectrum of services. Having completed more than 50 submissions for drug approval over the last 5 years, we remain a top choice for sponsors who are looking for innovation and demand high quality from their CRO partners.Senior leadership at MMS has more than two decades of hands-on drug development experience which helps support program-level strategy and execution of projects across multiple therapeutic areas. Continual staff training, innovative recruitment and motivating career opportunities help MMS retain the best talent and develop a strong, client-focused workforce across all global locations.Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients'​ lives worldwide.
See more MMS offers

Job description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
 
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

This role is a project-based consulting opportunity.

Responsibilities: 

  • Independently conduct vendor qualification audits and/or investigator site audits including relevant audit documents such as: audit plan, audit report and debrief presentations 
  • Vendor oversight and monitoring, as needed
  • Experience with performing investigations of errors investigations and risk assessments
  • Experience with hosting and interacting with regulatory authorities during an inspection
Requirements:
  • Minimum 5 years of experience in GCP auditing role within the CRO, Pharma, or Biotech industry
  • Bachelor’s Degree in a scientific, medical or clinical discipline
  • Travel may be required for onsite audits 
  • Expert knowledge of scientific principles and concepts
  • Proficiency with MS Office applications
  • Hands-on experience with clinical trial and pharmaceutical development            
  • 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
  • Proficient experience with 21 CFR Part 11, FDA, and GCP requirements
  • Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Clinical Trial PlanningRegulatory ComplianceAudit ManagementTitle 47 CFR Part 15ISO 20022Health Risk AssessmentsFDA RegulationsVendor ManagementAudit PlanningISO/IEC 27001

Other Skills

  • Teamwork
  • Communication
  • Problem Solving
  • Organizational Skills
Are you interested?

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