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Head Quality Compliance - Biologics (m/f) Job ID: 10557

Ihre Aufgaben
  • Develops, implements and supervises the operation of the Quality Management System

  • Ensures proper implementation and maintenance for all quality systems, especially during deviation investigations, corrective and preventive actions implementation and change control management

  • Interacts with regulatory authorities

  • Prepares the unit for pharmaceutical inspections and audits led by national and foreign authorities

  • Participates and represents the company in internal and external audits

  • Leads and manages the QA Compliance Team

  • Proper preparation and review of required GMP documents

  • Reviews and approves of supplier qualifications, and helps in preparation and review of relevant technical/quality agreements

  • Assesses, gives guidance and approves the documentation prepared on-site or provided byexternal entities. Develops and updates the system GMP documents. Approves Validation protocols and reports for the company

  • Oversees the change control process, makes sure that proposed changes are in compliance with GMP regulations and that change control management is in compliance with internal procedures of our company

  • Verifies compliance of GMP documentation in the unit with the internal and external applicable regulations before implementation

  • Ensures a review of all documentation generated from the production processes including batch records, environmental monitoring, cleaning records, equipment parameters/log books, process deviations and microbiology exception reports is performed

  • Maintenance and development of the Quality System in conjunction with the Production Dept. and Head of Quality Unit. Ensures compliance of Production and Quality Control with the QMS, GMP, EU, FDA and local requirements

  • Ensures that all explanatory actions in cases of quality deviations and complaints are properly conducted and closed (including root cause) in accordance with all relevant regulations and laws

  • Ensures, that all corrective and preventive actions are properly defined, planned, distributedand finalized in expected time

Auf Anfrage
Auf Anfrage
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobil + 49 152 295 555 62
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobile + 49 152 295 555 62
Mail larissa.weber@theentourage.de
Betreff Bewerbung für Job ID 10557 auf theentourage.de