Job Description

Job Description

  • Support Quality Assurance activities related to sterile manufacturing and filling operations.
  • Assist with the preparation, assessment and follow-up of change controls.
  • Support deviation investigations and ensure that the related documentation is complete and accurate.
  • Follow up on actions arising from deviations, change controls and other quality records.
  • Review manufacturing and quality documentation for completeness, consistency and GMP compliance.
  • Clarify incomplete or unclear documentation with internal stakeholders and the external manufacturing partner.
  • Monitor open quality records and support their timely progression and closure.
  • Maintain an overview of several ongoing quality topics and communicate outstanding actions.
  • Support the evaluation of quality issues within their practical manufacturing context.
  • Assist with batch record reviews following the i...

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