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, ensuring Takeda is professionally represented.
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.
Qualifications:
You have a degree in Pharmacy, Microbiology, Life Sciences, or an equivalent scientific discipline.
Solid professional experience in Quality Assurance; Quality Oversight or Regulatory Compliance, ideally in the pharmaceutical or biotech industry.
Solid knowledge of GMP regulations is a given for you.
Demonstrated written and oral communication skills and ability to work in a cross-functional team environment.
Strong interest and commitment to digital transformation and continuous improvement through data analytics and automation advantageous.
Able to thrive in a fast-paced environment with minimal direction.
You are characterized by a precise, reliable way of working and enjoy teamwork.
Fluent English skills complete your profile.
You will work in an international environment with a very renowned company.
#J-18808-Ljbffr