Gcp Auditor
hace 4 semanas
GCP AuditorLocation: Global Innovative Clinical Dept.Functions:
- Plan, lead, execute, report on, follow up and/or oversee audits held by both the GSMQA and by external auditors.
- Guarantee the execution of and compliance with any Quality Assurance Program established for the clinical studies.
- Host and coordinate any external audits/inspections conducted in the Scientific and Medical Area.
- Coordinate the Audit/inspection agenda internally.
- Prepare and review the documentation before Audit/inspection.
- Advisor and reviewer of Policies, Manuals, SOPs, WIs and Forms from the Scientific and Medical Area.
- Participate in the development of Quality Assurance SOPs (both new and existing).
- Participate in the organization of the SOP review and distribution procedure.
- Ensure the monitoring of and compliance with all the procedures described in the Quality System and corresponding to each area.
- Computerized System Validation Member in GxP environment working group.
Key Responsibilities:
- Review the Validation Package of documents: Validation Plan, IQ/OPQ/PQ Protocols/Reports, Change Assessment-Risk Analysis and Final Validation Report.
- Review the Quality System documents for using the system.
- Ensure documented training registration of the system end-users personnel.
- Ensure that in the execution of the validation tasks carried out the established internal policies and procedures are followed.
- Trainer and advisor in Good General Practices (GxP) to the company and/or external personnel.
- Conduct training for the company staff and/or external staff on GxP, Quality System documents and other quality assurance requirements deemed necessary.
- Solve doubts and provide advice on issues related to audits and GxP at Global and affiliate level.
- Act as mentor of new company employees and/or trainees.
- Provide technical guidance, mentoring and training on audit activities.
- Back-up in case of absence of the Head of the Global Scientific Medical Quality Assurance.
External Relationships:
- Health Regulatory Authorities
- Hospitals, Advisors, Service Providers
- Partners, Affiliates
- Quality associations
Required Studies:
- University degree in medical sciences
Quality Assurance training
Professional Experience:
- More than 10 years GxP experience in Pharmaceutical Industry or equivalent.
- More than 5 years as GCP/GVP auditor.
- Experience and/or interaction with local Health Authority.
- English Advanced Level.
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