Auditor für internes Drug Safety & Medical Affairs Audit mit GVP Fokus (m/f/d)

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

• Audit Planning/Preparation: Training on SOP for internal Audit Management incl. Attachments for Agenda, Audit Report, CAPA Plan, Provision of Audit Agenda
• Audit Conduct: Leading through the audit process, Definition and classification of audit observations/findings
• Audit Reporting: Provision of Audit Report draft for internal review (30 days after audit date), Provision of CAPA Plan, filled with Audit Observations/findings, Signing of final Audit Report (should be done latest after 45 days after audit date), Assessment and approval of defined CAPAs within CAPA Plan
• CAPA review until closure: Review, assessment and approval of closed CAPAs
• CSR Management, PSMF management, Aggregate Reports & Risk Management, Signal management and safety communication, Quality Management of PV processes (documents, training, audits, vendor oversight etc.), Medical Affairs processes that interface with GxP activities (e.g. Medical Enquiries, Managing Medical Information Requests)
• The following regulations can be used as guidelines: Regulation 726/2004, Directive 2001/83/EC, Commission Implementing regulation 520/2012, Good Vigilance Practices (GVP) Guideline, Applicable national regulations and guidelines, e.g. Medicines Act

• Solid experience in the GVP area (Good Pharmacovigilance Practices)
• Experience as an auditor in Drug Safety and Medical Affairs
• Expertise in working with the relevant authorities (EMA/AGES)
• Fluent in English and German

• Exciting auditing role in a dynamic pharmaceutical environment.

Ihr Kontakt

Ansprechpartner
Corina Nauschnegg

Referenznummer
858921/1

Kontakt aufnehmen
E-Mail: corina.nauschnegg@hays.at

Anstellungsart
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