QC Project Lead

Gefunden in: beBee S CH - vor 4 Wochen

Wallis, Schweiz Talentor Switzerland Vollzeit

Contract duration: 31/10/2024



Responsibilities:



  • Provides input to program management regarding Quality Control capabilities and requirements for method qualification/validation.
  • Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
  • Provides technical review of Statements of Work and Work packages to support contract manufacturing activities.
  • Provides Quality Control representation to project team meetings.
  • Responsible for relaying pertinent information such as production schedules and information requests to applicable Quality Control groups. Provides routine feedback regarding tech transfer and testing status.
  • Relays status updates in a timely and accurate manner. Writes, reviews, and/or approves Method SOP/Forms, Sampling Plans, and Specifications. Leads tech transfer activities related to Quality Control including generation of a Quality Control method transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines. Works in cooperation with TD to design qualification, and validation protocols.
  • May participate in the execution of such protocols as needed to support lab(s).
  • Assists with responses to audits, deviations, out of specification investigations, and corrective/preventative actions.


Requirements:



  • Work Experience in Quality Control 5-10 years
  • Fluent in English and German
  • Experience in GMP, analytics for small molecules a must

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