Quality Lead (m/w/d).

Job ID: 11135

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Discipline
Quality/Production
Type of employment
Project Consulting
Company
Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
Responsibilities
  • Performing the function of a quality manager in a biosynthetic production facility to ensure the quality of drug substances and their intermediate products.
  • Responsible supervision and optimization of quality control systems in the production considering current GMP-standards and pharmaceutical guidelines, e.g. changes, deviations, CAPA, annual product evaluation, etc.
  • Evaluation and follow-up of change requests, deviations, as well as  OOT-/OOS- reports in the process
  • Review and approval of quality relevant and operational documentation, such as Operational Manuals (HAW), SOPs, PQRs, qualification and validation plans
  • Supporting projects in the production regarding quality relevant issues
  • Conception and organization of process and cleaning validations
  • Participation in the actualization of pharmaceutical-technical documentation
  • Realization of quality concepts in the production, facilitating successful audit performance through application of expert knowledge in compliance with regulatory requirements
  • Preparation of audits and external inspections by authorities and maintaining of inspection readiness
  • Collaboration in an interdisciplinary team of production, engineering, quality and contractors
Requirements
  • Diploma in any of the fields of biology, biotechnology, chemistry or equivalent education
  • Experience in quality management of biosynthetic drug substance production preferred
  • 3 years experience in quality management
  • 3 years experience in pharmaceutical production
  • German (native in speaking and writing) 
  • English (good in reading, writing and speaking)
  • Good knowledge of GMP
Region
Mitte