Global GxP Expert Auditor
Novartis Farmacéutica, S.A.
Barcelona, Spain
hace 5 días

Job Description

Global Senior GCP / PV Auditor

How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?

As Global Senior GCP / PV Auditor, you will be responsible for leading, supporting and reporting independent GCP and PV audits and approving follow-up CAPAs according to Novartis guidelines and GCP regulations.

Your responsibilities include, but not limited to :

  • Supporting the strategic development of an effective global risk-based audit strategy and programme; collecting, collating and incorporating input into audit strategy and plan
  • Leading, planning, conducting, documenting and following-up of global quality regulatory compliance audits and assessments of GCP / GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents.
  • Performing activities with a high degree of independence

  • Providing technical guidance, leadership, mentoring and training of other auditors on audit related activities
  • Assessing the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
  • Identifying and communicating quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommending remediation
  • Leading compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement as requested
  • Proactively researching local and global initiatives, trends and events that impact maintenance of compliance
  • Maintaining current knowledge of regulations, standards, and guidance documents
  • Minimum requirements

  • Bachelors / Masters in Natural Sciences, Biological Sciences or similar subject
  • Around 7 years or more experience in GCP or PV both would be advantageous but not essential
  • Flexibility and willing to travel up to 60%
  • Experience dealing with Health Authority inspections is key
  • Strong knowledge of GCP, PV, GxP regulations
  • Good knowledge of computer systems validation and 21CFR Part 11 requirements
  • Ability to lead audit teams and operate successfully in various team capacities
  • Fluency in English is essential written and spoken. Additional languages are welcome
  • You’ll receive : Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours

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