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Senior Manager GMP Quality Assurance (f/m/d)

Apply NowEmail Me Job ID R0017849 Date posted 03/11/2020 Location: Singen (Hohentwiel), Germany

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Job Description

Responsiblefor

  • Manages QC testing activities at Contract Manufacturing Operations (CMO) and contract testing laboratories
  • Serves/leads as Subject Matter Expert (SME) for analytical methods in support of clinical and commercial programs across the organization, particularly as it applies to
    • method transfers and method validation activities
    • managing OOS investigation/ laboratory investigation
  • Collaborates with national control laboratories on in-country release testing procedures
  • Serves as SME for microbiological methods and procedures (like bioburden, endotoxin, microbial identification, environmental monitoring and sterility testing)
  • Establishes and maintains product specifications for vaccines product
  • Monitoring of method performance and manages method life cycle
  • Oversight of cell and virus seed bank manufacturing, testing, characterization and inventory
  • Collaboration with analytical development teams on new methods and method improvements
  • Control of standards and reagents inventory

Your Profile

  • Master degree inmicrobiology, pharmaceutical science, biotechnology, chemistry or closely related field with a minimum of 3 years of leadership experience within a QC laboratory or QA organization (with oversight of QC activities)
  • Knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements
  • Experience in leading continuous improvement projects within QC laboratories, including developing and implementing QC procedures
  • Experience in vaccines and biologics manufacturing and testing and related guidelines
  • English and German are required
  • A thorough understanding of QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred
  • Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred

Takeda GmbH

Human Resources Germany

Robert-Bosch-Straße 8, 78224 Singen
Tel.: +49 7531-84 2108

germany.jobs@takeda.com
http://www.takeda.com/de-de/

Locations

Singen, Germany

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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