Life Sciences Consultant - Cadiz, United States - Nexus Dynamics

Nexus Dynamics
Nexus Dynamics
Verified Company
Cadiz, United States

1 month ago

Meredith Sinclair

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Meredith Sinclair

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Description

Avertim is an independent, Europe-wide management consulting firm with approximately 300 consultants. Since our founding in 2007 in Brussels, we have successfully supported our clients in implementing optimal strategies in organizations and processes, as well as in using innovative technologies to increase performance. We realize our clients' ideas and projects through a deep understanding of strategic business advantages, combined with a solution-oriented, pragmatic approach that complies with the complex regulatory requirements of legislators and international supervisory authorities.

In Germany, our consulting focus is on the pharmaceutical, medical technology, biotechnology, and chemical industries. For our branch in Frankfurt am Main, we are looking for you as a (Senior) Consultant Quality & Compliance (m/f/d).

Your responsibilities

  • Conceptualization, optimization, and implementation of quality management processes and systems to ensure GMP compliance
  • Creation of GMP-compliant documentation for conducting gap analyses, risk analyses, and remediation/CAPA strategies
  • Preparation, support, and follow-up of audits and regulatory inspections
  • Implementation of qualifications and validations in the GMP environment
  • Writing and reviewing manufacturing instructions, test protocols, SOPs, and validation documents
  • Implementation and improvement of relevant quality systems such as change control, deviation management, and batch record review
  • Development and implementation of pragmatic
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