Gcp Auditor
hace 3 semanas
GCP AuditorLocation: Barcelona, España
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.
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 AuthoritiesHospitals, Advisors, Service ProvidersPartners, AffiliatesQuality associations
Required Studies:
University degree in medical sciences
Quality Assurance trainingProfessional 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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