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Lead Vaccine External Supply QA (f/m/d)

応募後で応募 求人ID R0026360 掲載日 06/15/2021 Location:Singen (Hohentwiel), Germany; Zurich, Switzerland

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Job Description

YourAccountabilities

  • Responsible for day-to-day interactions with contract facilities (CMOs) and internal partners.Ensure cGMP requirements are met at contract facilities and internal operations
  • Approve manufacturing and testing deviations and investigations into out-of-specification results
  • Review and approve batch production records and test records.
  • Perform internal batch disposition
  • Maintain a Quality Management System (QMS) and ensure continuous improvements
  • Provide support for vaccines tech transfer on DS and DP level
  • Review and approve documentation for tech transfer, andfor qualification and validation of analytical methods and manufacturing processes
  • Support audits at CMO, testing, packaging, and warehouse/distribution operations
  • Conduct and support internal audits
  • Provide support for regulatory submissions

Your Profile

  • Bachelor’s Degree or higher in Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline
  • Several years of experience in quality within the pharmaceuticals, biologics.
  • GMP - experience in vaccines or other biologics
  • Experience with supporting product inspections from global Regulatory Authorities is required
  • Experience with global product launch and early commercial life cycle phase would be beneficial
  • Effectively represent Quality Assurance, both internally and externally
  • Experience in routine office software packages and specialized software applications as appropriate
  • Excellent communication skills both oral and written

Takeda GmbH

Human Resources Germany

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

germany.jobs@takeda.com
www.takedajobs.com

Locations

Singen, Germany

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
応募後で応募