Quality Management Specialist (m/f) Our client is one of the major pharmaceutical companies in Japan. Its European research center is conducting a multitude of activities in the fields of clinical research, pharmacovigilance, regulatory affairs and quality assurance. The company consists of 31,000 employees worldwide and has an annual revenue of 4.5 billion. Our client, the research center, is based in Frankfurt. An office-based Quality Management Specialist with 4 years of experience in the pharmaceutical industry is required to support the Quality Management department on site. He/She will be reporting to the Head of Quality Management. Key Responsibilities - Support compliance of clinical trials with regulatory requirements, ICH-Good Clinical Practice (GCP) guidelines and study protocols - Maintain compliance of our Quality Systems within Europe (Clinical Development, Regulatory Affairs, Pharmacovigilance, Investigational Medicinal Product (IMP) management with regulations and guidelines - Maintain an adequate audit plan for trials and systems (global and study-specific) in collaboration with our research institutes in Japan and the U.S - Review our standard operating procedures and working procedures - Collaborate on projects together with other functions such as IMP management, Pharmacovigilance, Regulatory Affairs etc. - Ensure continuous improvement and support GCP training Qualification Minimum - Degree in natural science or equivalent - 4 years of pharmaceutical industry experience - 2 years in Monitoring and/or Clinical Quality Assurance, GCP Auditing - Communication skills, team player, interpersonal skills, willingness to travel - Sound knowledge in ICH-Good Clinical Practice guidelines and related regulations Preferable in addition - Good Manufacturing Practice experience related to IMP-management/release - Knowledge/experience in Medical Device development and regulations (Medizinproduktegesetz) Our client offers an interesting and diversified role within a small team. In addition to an attractive salary, the company offers training opportunities and employee benefits associated with a large organization. We look forward to receiving your detailed application, complete with your salary expectations and earliest possible starting date. Please send your application via e-mail to personal@compleo.de In case of further questions please contact Ms. Evi Hallermayer. Tel. +49-(0)89-700 76 58-25 compleo AG attn. Ms. Evi Hallermayer Am Knie 8 81241 Munich Germany Tel. +49-(0)89-700 76 58-50 Fax +49-(0)89-700 76 58-21

Dienstort: München
Anzahl der offenen Positionen: 1
Anfangsdatum: 2008-05-01
Stundenanzahl: 40 h
Vertragsart: unbefristet
Führerschein: Reisebereitschaft zeitweise erforderlich
Gehalt: Leistungsbezogen plus Bonuszahlungen
Chiffre: 10000-1021017244-S
Modifiziert: 10.05.2008
Bewerbungsart: E-Mail
E-mail Addresse: personal@compleo.de