Auditor für internes Drug Safety & Medical Affairs Audit mit GVP Fokus (m/f/d)
Responsibilities
- 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
Profile
- 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
Benefits
- Exciting auditing role in a dynamic pharmaceutical environment.
About Hays
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.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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