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Quality Manager, Vaccine Quality (f/m/d)

Apply NowEmail Me Job ID R0011126 Date posted 03/11/2020 Location: Singen (Hohentwiel), Germany

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Job Description

YourAccountabilities

  • Responsible for day-to-day interactions with contract manufacturing facilities,and ensure GMP documentation of activities at contract facilities
  • Approve manufacturing and testing deviations and investigations into out-of-specification results
  • Conduct and/or lead investigations related to Good Manufacturing Practice (GMP) events or observations associated with audits, batch records, and complaints
  • Prepare documentation for vaccines batch disposition
  • Review and approve internal/external investigations and CAPAs
  • Review and approve batch and test records, prepare annual product reviews andprocess technical complaints
  • Review and approve documentation for tech transfer, change control and validation of analytical methods and manufacturing processes
  • Assist with internal and external audits at CMO, testing, packaging, and warehouse/distribution sites
  • Maintain GMP records according to applicable regulatory requirements and Takeda policy
  • Draft and review internal GMP documents such as standard operating procedures, certificates of analysis, and specifications.Provide QA tracking and trending information to QA management
  • Maintains culture of teamwork, cooperation and continuous improvement

Your Profile

  • Bachelor's Degree or higher in Chemistry, Biology, Life Sciences, or equivalent scientific discipline
  • First experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industries
  • Good Manufacturing Practice quality assurance experience desirable
  • Excellent communication skills
  • German and English are required
  • Experience with authority inspections 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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