Quality Control Manager (m/f/d).

Job ID: 10858

Jetzt bewerben
Disziplin
Quality/Production
Stellenart
Project Consulting
Ihre Aufgaben
  • Creates and implements laboratory processes and controls in line with regulatory requirements and internal policies for areas of responsibility, ensuring consistency within the organization.
  • Leads tech transfer activities related to Quality Control including generation of a Quality Control master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
  • Writes, reviews, and approves test records/forms, sampling plans, and specifications
  • Provides technical review of statements of work to support manufacturing activities
  • Works in cooperation with Bioanalytical Services to design qualification, and validation protocols.  Participates in the execution of such protocols as needed to support lab(s).
  • Writes qualification and validation protocols and executes analytical method validation.
  • Develops Life-Cycle Management plans for all analytical methods from raw material inspection to final release
  • Ensures regulatory inspection readiness; participates in audits as inspections as require and assists with responses to audits, deviations, out of specification investigations, and corrective/preventative Actions.
Ihr Anforderungsprofil
  • An international work environment
  • An attractive, market-oriented salary
  • Training of new employees.
  • A globally successful and constantly growing company
Region
Mitte