QA Manager External Suppliers
Vor 5 Tagen
Overview:
Expleo offers a unique range of integrated engineering, quality and strategic consulting services for digital transformation. At a time of unprecedented technological acceleration, we are the trusted partner of innovative companies. We help them develop a competitive edge and improve the daily lives of millions of people.
Joining Expleo Switzerland means:
- Technical and human support for each project and effective career monitoring
- Take part in training courses to develop your professional skills
- Take part in special dedicated events
- Join a dynamic team
**Responsibilities**:
To support our growth in German part of Switzerland, we are looking for a:
QA Manager External Suppliers
Based in Zurich area, you will be responsible as QA Manager for External Suppliers/Contract Manufacturers. 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.
**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 Biotech 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.
- 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 and 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.
- ** 7 years of professional experience in Biotech Quality Assurance ( deviations and process improvement experience ) **; Quality Oversight or Regulatory Compliance, ideally in the pharmaceutical or biotech industry in GMP environment.
- 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.
- ** Fluent in English and German ( English essential /German preferred )
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