GCP Auditor
Compliance
Madrid, Spain
hace 8 horas

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 .

Please submit an English version of your CV.

Responsibilities :

  • Plan and conduct GCP audits in the Medical Device, Biological Drug / Agent, and / or Pharmaceutical realm. Audits may include investigator site, sponsor, Mock Inspection, process, quality assurance / quality management system, software / computer system qualification and validation, vendor (including vendor qualification), and / or bioanalytical / bioequivalent / pharmacokinetic.
  • Report Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.
  • Assist with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required by the client.
  • Write confirmation letters, and audit plans, agendas, reports and other required audit documentation.
  • Provide drafts of required documents, and finalize following internal QA and sponsor reviews according to project timeline.
  • Provide GCP and inspectional preparedness training to clinical sites, vendors, and sponsors as required by client.
  • Provide good documentation training to auditees as required by client.
  • Perform gap analysis of SOPs and procedures as required by client.
  • Review, develop and revise client procedures, guidance documents, form templates, and quality documentation as required by client.
  • Perform all audit-related activities in accordance with MMS procedures and using MMS document templates, or client procedures and templates as required by the client.
  • Required Qualifications :

  • Bachelor’s degree or higher in biomedical, nursing or related life science discipline required.
  • Minimum 5 years relevant auditing experience preferred.
  • Minimum 2 years SOP development experience preferred.
  • Comprehensive understanding of ICH Guidelines i.e., ICH E6 (R1) and ICH E6 (R2) , appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.
  • Training to and understanding GDPR requirements relative to clinical research preferred.
  • Excellent demonstrated verbal and written communication skills
  • Ability to travel up to 50%, both domestically and internationally.
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