Global GMP Pharma Auditor (Cornu, Prahova) in Câmpina, Județul Prahova

Global GMP Auditor Aenova

For our production site in Cornu, Romania

The Aenova Group is one of the leading companies in the pharmaceutical and healthcare industry. With high quality standards, innovative technologies, and a clear future orientation, Aenova has become Europe's market leader for the development and production of all common dosage forms and product groups in the business-to-business sector. The company, which has its headquarters near Munich (Germany), operates 15 production sites and several sales offices in ten countries throughout the world. More than 4,300 employees contribute to the group’s success.

What can you expect?

Job Purpose
  • Conduct GMP and Quality System audits to own sites/entities (e.g., production sites, commercial affiliates, and development entities as applicable) and Key Thirds party contractors or suppliers as Lead or supportive auditor, to monitor that all the aspects of the operational business comply with GxP and regulatory requirements and Aenova Group Quality Manual and Policies.
  • Conduct all necessary assigned audits (from the yearly Global Audit Plan, pre-qualification, mock-pai, ad-hoc or for-cause audits) including the preparation phase and communication cross-sites to collect all the audit info.
  • Provide the finalized signed Audit Reports to the Audit Managers assigned for the respective supplier.
  • Approve Corrective and Preventive Actions which are necessary due to audit findings.
  • Support local auditors training sessions, audit planning and Risk Assessments (e.g., for Supplier Qualification)
  • Identify and report Critical Compliance Risks and Gaps during audit activities.
  • Provide effective support during Regulatory Inspections as requested by QA Operations/sites.
  • Perform auditing activities required in the electronic system DHCV Audit Module.
Key Performance Indicators
  • Assigned audits are conducted in accordance with the plan, around 30 audits/calendar year, mainly EU area.
  • Reports are comprehensive, accurate and to an agreed standard, performed in timely manner (one calendar month).
  • All CAPAs plans managed adequately (requested to the auditee, verified, and approved).
  • All trainings and compliance site support performed.

What should you bring?

  • University degree (or equal) in Pharmacy, Chemistry, Microbiology, Biology, Biochemistry, or another related science additional knowledge in Quality Assurance/Compliance and Auditing.
  • Experience: Minimum 5 years of experience in pharmaceutical industry, e.g., Production, QA, Quality Control, Development.
  • Prior Auditing experience to be proven (by training and in-field expertise).
  • Languages: English fluent in speaking and writing, 2nd language desirable.
  • Personal profile: Strong analytical skills, travel flexibility, very good communication, and organizational skills.
Have we inspired your curiosity?
For any questions, please contact the human resources department at Cornu: +40 244 306 538

Expirat 13.02.2024

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