Gcp Auditor

hace 4 semanas


Barcelona, Barcelona, España Mcr International A tiempo completo
Job Title:

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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