(Associate) Consultant Quality Assurance (m/w/d)
ProPharma Group MIS Limited
Berlin, Germany
vor 6 Tg.

Job Description

As a Consultant Quality Assurance, essential responsibilities include :

Internal QA :

  • You will ensure that the processes in the Berlin office comply with the global QM-system.
  • You will maintain and further develop the local QM system.
  • You will participate in the planning, definition and implementation of quality policies.
  • You will create, update and review internal SOPs and working instructions.
  • You will prepare, execute and post process internal audits, customer audits and authority inspections.
  • You will maintain and monitor quality records on deviations, CAPA, complaints and audits.
  • You will monitor the administration of document control and training programs.
  • You will have a working knowledge of Good Pharmacovigilance Practices (GVP)
  • External QA with clients :

  • You will help clients identify processes that require quality management measures within their organization.
  • You will build and maintain quality systems / processes for clients.
  • You will prepare the necessary SOPs in accordance to the legal requirements and applicable standards.
  • You will prepare or review quality agreements.
  • You will conduct audits and coordinate inspections with the authorities for clients.
  • You will submit applications for wholesale dealer licenses or narcotics license on behalf of the clients. as well as support and advice contract manufacturers / CMOs.
  • You will advise clients on quality issues and ensure compliance / implementation of quality guidelines.
  • Qualifications

    Qualified candidates must have :

  • You have an academic degree or equivalent work-related experience in quality management at a pharmaceutical company, a contract-
  • manufacturing organization or a medical device manufacturer.

  • You are fluent in German & English languages.
  • You possess strong analytical, communication and organizational skills as well as problem-solving and consulting competence.
  • You have demonstrated ability to learn and grasp new topics and information and quickly.
  • You have the ability to manage and prioritize multiple tasks and projects.
  • You have very good MS Office skills.
  • You are ready / open to travel to clients and other ProPharma sites.
  • You have a hands on mentality and the flexibility to adopt to changing situations.
  • You are a team player but can also work autonomously with limited supervision.
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