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Gxp Auditor

2 weeks ago

Tuas, Singapore MMS Full time

MMS is looking for GxP Auditors who are available as a project-based consultant.

**Responsibilities**:

- Plan and conduct GxP (GCP, GLP, and/or GMP) 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.
- Minimum 2 years GxP training 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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