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Quality Manager (GCP / GLP) (m / f / d)

Quality Manager (GCP / GLP) (m / f / d)

ProtaGene GmbHHeidelberg, DE
Vor 8 Tagen
Stellenbeschreibung

Job description

  • Assisting in the expansion and maintenance of the Quality Management System, including future certification and accreditation responsibilities.
  • Performing internal audits in accordance with GCLP, GCP and GLP guidelines.
  • Participating in audits of external customers and regulatory agencies.
  • Participating in qualification of equipment, systems, and suppliers.
  • Organizing and overseeing employee training.
  • Creating, revising, and reviewing documents such as SOPs and work instructions.
  • CAPA, deviation, risk analysis and change control management.
  • Active participation in quality assurance of ongoing laboratory and data analysis processes.
  • Creation and review of qualification and validation documents.

Job requirements

  • Completed scientific studies in biology, biotechnology, medicine, pharmacy or comparable natural / biological sciences.
  • Experience in quality assurance, preferably in the field of biotechnology or pharmacy.
  • Knowledge of current international regulations for GCP / GLP direct experience would be an advantage.
  • Experience with accreditation / certification procedures for GLP or in the DIN-EN-ISO field desirable.
  • Experience with computer-based system validation and cloud-based IT systems is an advantage.
  • Very good knowledge of written and spoken English is mandatory, very good knowledge of German an asset.
  • Strong quality awareness and ability to apply quality knowledge in practical work.
  • Integrity, commitment, and a motivated work ethic.
  • Ability to work in a team and independently.

    • We offer

  • Responsible and varied tasks in a motivating working environment.
  • A permanent position in a dynamically growing international life science group with over 200 employees.
  • Optimal induction and training opportunities as well as individual development options.
  • Appreciation, openness and respect as well as a lively feedback culture.
  • Flat hierarchies, short decision-making processes and flexibility.
  • Comprehensive health management.
  • Job ticket.
  • Job bike.
  • Regular company and team events.