Want to be notified the moment a job has been posted? Setup Job Alerts
GCP AuditorMMS Holdings Inc.
MM S is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, 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 www.mmsholdings.com or follow MMS on LinkedIn (https://www.
linkedin.com/company/mms-holdings-inc-/) . This is a project based consulting position.
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 do....