Quality Assurance Manager
QA- Manager
Experis is the global leader in professional resourcing and project-based workforce solutions.
In the role as QA Manager for External Suppliers/Contract Manufacturers, you will play a central role in our company. Your task will be to manage the Quality oversight of our external partners and continuously improve performance.
In this position, you will report to the Lead, External Supplier QA.
Locations
Zürich, Switzerland
Singen, Germany (travel to Singen site (Germany) twice a month)
Your main 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.
Your profile:
- You have a degree in Pharmacy, Microbiology, Life Sciences, or an equivalent scientific discipline.
- Several years of 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 is a plus.
- 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.
If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar Write an email or at +41 61 282 22 23
À propos de l'entreprise
