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Startseite Jobs, Karriere Wissenschaft Quality Compliance Manager (m/f/d) (Wiesbaden, Westend)

Quality Compliance Manager (m/f/d)

Quality Compliance Manager (m/f/d) - Wiesbaden 
Berufserfahrung
wünschenswert
Firma
palleos healthcare GmbH
PLZ der Firma
65183
Ort der Firma
Wiesbaden
Branche
chemie, pharma & medizin allg.; medizintechnik
Palleos Healthcare GmbH is a service company within clinical research with a focus on oncological research projects. Palleos Healthcare GmbH is a full service CRO offering comprehensive services for clinical research projects with IMPs (Phase I-IV, NIS) and medical devices (IVD). In addition, Palleos Healthcare GmbH in cooperation with Phaon Scientific GmbH offers innovative complete solutions for carrying out research projects for pharmaceutical companies, manufacturers and CROs. Since 2016, Palleos Healthcare GmbH has been a sponsor of several oncological studies. For the strengthening of our team we are looking for a Job description The Quality Compliance Manager (QCM) is responsible to implement Quality Control processes throughout the company’s business and is involved in: Setting up the Company SOPs and maintenance of the SOPs as well as training on the SOPs of the palleos staff Setting up and follow up the CAPA plan in the company until resolution of the CAPAs Organizing or may perform training on ICH-GCP topics The preparation of the annual audit program of palleos various departments and performing the internal audits as per the audit program including audit reports and follow up of the findings until resolution Performing vendor qualifications and study site audits as needed The QCM is a support in the implementation of tasks and projects according to the latest regulatory requirements of GCP and ISO 14155 , ISO 20916 as well as country-specific laws (in particular AMG and MPG) The QCM is the Company contact for all sponsor audit activities or regulatory inspections. The QCM escalates significant issues to upper management and identify performance gaps relative to current and new regulations, improve efficiency and adoption of best practices; recommend appropriate corrective actions Design or implement improvements in communication, monitoring, or enforcement of compliance standards Requirement profile Is qualified as a Quality Compliance Manager with several years of work experience in the field At least Bachelor’s level degree in life sciences, pharmacy, preferred Profound knowledge of the ICH-GCP in the clinical research field and of the regulatory requirement and the national Laws applicable for the clinical research field (mainly Germany , international experience would be helpful) Demonstrated capabilities for preparing and performing trainings audits Very good written and spoken knowledge of German and English Secure handling of all Microsoft Office applications Independent manner of acting, very good communicative and organizational skills Contact: palleos healthcare GmbH Taunusstraße 5a 65183 Wiesbaden Web: www.palleos.com If we catched your attention we would be happy to receive your application by mail with the reference number YF3923234 to Ms. Dena Bozkurt (Dena.Bozkurt@palleos.com) Quality Compliance Manager (m/f/d) Festanstellung Vollzeit palleos healthcare GmbH Wiesbaden Chemie Naturwissenschaft Pharmazie Physik Qualität Qualitätsmanagement Rechtswesen Studium Chemie, Pharma & Medizin allg.,Medizintechnik Biotechnologie,Naturwissenschaften,Pharmazie,Ingenieur, Technik,Qualitätsmanagement,Rechtswesen Festanstellung Vollzeit Mit Berufserfahrung Die Palleos Healthcare GmbH ist ein Dienstleistungsunternehmen innerhalb der klinischen Forschung.

Ausschreibendes Unternehmen: palleos healthcare GmbH
Ausschreibungsdatum: 2019-11-13
Vertragsart: Festanstellung Vollzeit
Berufserfahrung: 1-2 Jahre
Tätigkeitsbereich(e): Biotechnologie; Naturwissenschaften; Pharmazie; Ingenieur, Technik; Qualitätsmanagement; Rechtswesen
Branchen: Chemie, Pharma & Medizin allg.; Medizintechnik
Einsatzort(e): 65183 Wiesbaden

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65183 Wiesbaden
65183 Wiesbaden
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Anzeigendatum
11.12.2019
Anzeigenkennung
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