Quality Control at Sandoz
Germany, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

16 Dec, 26

Salary

80000.0

Posted On

17 Sep, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Biotechnology

Description
  • Management of the microbiology laboratory, taking into account the pharmaceutical regulations and the BG guidelines for laboratory safety.
  • Interim management of the packaging laboratory
  • Organization and ensuring the proper execution of microbiological investigations
  • Conducting risk assessments in microbiological matters
  • Ensuring, defining and verifying environmental monitoring at the Neustadt plant
  • Assistance in ensuring, defining and verifying proper sampling at the Neustadt plant
  • Coordination of training and development plans
  • Support in organizing the examination of finished products, intermediate products, active ingredients, stability samples and packaging materials
  • Assistance with the control and monitoring of the qualification, calibration and maintenance of testing facilities and equipment, including equipment release.
  • Participation in the validation of methods and the introduction of new control procedures
  • Creation, updating and, if necessary, review of quality records, method specifications and SOPs in the aforementioned laboratory.
  • Handling deviations and OOX results, complaints and change requests
  • Representation of the laboratory supervisor qPCR, the laboratory supervisor chromatography and chemical/physical laboratory and the laboratory supervisor enzyme laboratory


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Responsibilities
  • Management of the microbiology laboratory, taking into account the pharmaceutical regulations and the BG guidelines for laboratory safety.
  • Interim management of the packaging laboratory
  • Organization and ensuring the proper execution of microbiological investigations
  • Conducting risk assessments in microbiological matters
  • Ensuring, defining and verifying environmental monitoring at the Neustadt plant
  • Assistance in ensuring, defining and verifying proper sampling at the Neustadt plant
  • Coordination of training and development plans
  • Support in organizing the examination of finished products, intermediate products, active ingredients, stability samples and packaging materials
  • Assistance with the control and monitoring of the qualification, calibration and maintenance of testing facilities and equipment, including equipment release.
  • Participation in the validation of methods and the introduction of new control procedures
  • Creation, updating and, if necessary, review of quality records, method specifications and SOPs in the aforementioned laboratory.
  • Handling deviations and OOX results, complaints and change requests
  • Representation of the laboratory supervisor qPCR, the laboratory supervisor chromatography and chemical/physical laboratory and the laboratory supervisor enzyme laboratory


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