Quality Assurance Manager/External Suppliers

Duration: 18 months

Responsibilities:

• GMP-compliant batch record review and approval of batch documentation as well as timely batch evaluation for externally manufactured products within the responsibility of Vaccine External Supplier Quality (ESQA).
• Preparation and approval of documents for batch release by the responsible institutes/authorities.
• Management of deviations and changes as well as management and tracking of CAPA measures and other QMS documents for external products within the responsibility of ESQA.
• Daily collaboration and communication with external partners
• Support in coordinating complaint handling with external partners as well as with global and local functions.
• Support in the preparation of inspections by regulatory authorities, as well as internal inspections and global audits at external partners.
• Coordination of documents required by the regulatory department for registration purposes.
• Coordination of Quality Agreements (QAGs).
• Support in the creation of global quality metrics/KPIs for external partners.

Requirements:

• You have a degree in Pharmacy, Microbiology, Life Sciences, or an equivalent scientific discipline.
• Min 5 years of professional experience in Quality Assurance; Quality Oversight or Regulatory Compliance, ideally in the pharmaceutical or biotech industry.
• Solid knowledge of GMP regulations