Quality Manager (m/f/d)
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
Profile
- 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
Benefits
- You will work in an international environment
- A very renowned company
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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