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NOVRJP00001638 Clinical Quality Assurance (m/w/d)

  • Type Temporary
  • Salary Verhandelbar
  • Location Holzkirchen (83607), Bayern
  • Sectors Pharma & Biotech

Gesucht: Clinical Quality Assurance (m/w/d) in Arbeitnehmerüberlassung

Ihre Aufgaben in Clinical Quality Assurance (m/w/d)

Proactively oversee the Clinical Quality Risk Management process and submission/inspection readiness activities and ensure that processes are under control.

Provide robust quality oversight in the following areas of clinical development:

  • Proactively support / collaborate with key stakeholders to ensure that risks are identified, regularly reviewed, communicated and controlled.
  • Support deviation/incident management for deviations pertinent to the programs being assigned and collaborate with other QA teams and business to drive continuous im-provement.
  • Provide regulatory intelligence guidance to day to day questions arising from Clinical tri-als deliverables
  • Participate in review and approval of key Clinical Study documents (e.g., Study Protocols, Monitoring Plans and Clinical Study Reports).
  • Collaborate with other QA functions and business to drive outsourced activities
  • Support inspection management (preparation, hosting, follow-up) in collaboration with other QA groups and business functions.
  • Support audit planning, management and follow-up

Support development and implementation of Quality Management Systems at global and local level, as applicable.

Ihr Profil

  • Bachelor Degree in LifeSciences, PharmacyorMedicines
  • Fluent in English, knowledge of other languages (e.g., German) a plus but not required
  • Minimum 6 years of experience in regulated activities (GCP/PV), clinical development and/or QA positions
  • Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development
  • Ability to work independently and in a global/matrix environment
  • Two or more years' experience in managing projects
  • Ability to effectively interact with and present to senior management, as well as to external audiences and inspectors
  • Strong skills in GCP, quality and/or clinical development; Experience in Late Phase Clinical Development desirable
  • Experience with managing Authority inspections desirable
  • Auditing Experience desirable
  • Strong interpersonal, communication, negotiation, and problem solving skills.

Rahmendaten

  • Projektstart: ab sofort
  • Projektdauer: 4 Monate, in Arbeitnehmerüberlassung
  • Einsatzort: Holzkirchen

Interesse geweckt?

Wenn Ihnen die Stelle als Clinical Quality Assurance (m/w/d) zusagt, bewerben Sie sich so schnell wie möglich! Senden Sie Ihren Lebenslauf direkt über den Link auf der Webseite z.H. Frau Rebecca Brian.

Fragen zur Stelle beantworte ich gerne unter +49 (0) 69 264 89 8060.

Ich freue mich auf Ihre Unterlagen!

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