Quality Assurance Lead

vor 20 Stunden


Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit
End to End Quality Stewardship

Our company is an innovative international biopharmaceutical organization with a strong presence in Basel. Our intense R&D activities have given rise to an exciting pipeline of new promising drugs, many of which have successfully reached commercialization stage. With a robust portfolio of on-market products and an extensive portfolio of pre-market assets, we cover the entire value chain. Our focus is on late-stage research and development, patient access, and commercialisation. This is realised through co-development agreements with international big pharma. As a member of our Global QA Team, you will serve as Single Point of Contact for all QA matters. From release of API, Drug Product, and Finished Goods, you will provide end-to-end quality stewardship of your assigned product from development to delivery to warehouse. Your responsibilities include: * Acting as Subject Matter Expert (SME) for the organization and product teams in GMP/GDP related topics* Pursuing compliance and quality-related topics both internally and externally with Contract Manufacturing Organizations (CMOs) and suppliers* Representing QA in project teams for tech transfers or launches of product to new markets* Handling and assessing deviations, change controls, and supporting product complaint investigations* Releasing products on QP Delegate* Participating in and supporting external and internal audits including authority inspections* Developing quality assurance standards and company processes.

  • Pursue compliance and quality-related topics both internally and externally with CMOs and suppliers.
  • QA representative in project teams for tech transfers or launches of product to new markets.
  • Handle and assess deviations, change controls, and support in product complaint investigations.
  • Release of products on QP Delegate.
  • Participate and support both external and internal audits including also authority inspections.
  • Develop quality assurance standards and company processes.


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