Quality System Manager
Location: SwitzerlandSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Stadt Switzerland.
Our client is a BioPharma company
ROLE DESCRIPTION
Our client is seeking talented people to join their team in Quality Assurance in order to support the implementation and the improvement of our Quality Management System (QMS) throughout various departments within R&D. As part of the group, your primary mission is to research and develop new products with the potential to reduce risks. You will actively participate in the development and maintenance of internal Quality requirements and the implementation of GxP-compliant Quality Management System (QMS).You will audit the processes and the quality documentation from development to scale-up and the technology transfer of developed products by R&D. In parallel, you will ensure the audit readiness of the organization for inspections by external regulatory bodies
RESPONSIBILITIES
- Audit the processes and quality documentation from development to scale-up and technology transfer of products developed by R&D
- Assist in the development of metric reports to QA management of all issues related to the outcome of the audits
- Support the business functions in establishing and implementing CAPA
- Create, advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions
- Support the establishment and maintenance of internal and external quality standards, to assess compliance with internal QMS and GxP principles
- Prepare the organization for audit readiness by external regulatory bodies and coordinate these activities with Operations
- Remain up-to-date with the evolution of the regulatory framework concerning GxP principles, FDA guidances and other relevant quality standards
REQUIREMENTS
- You will have a Masters degree in Engineering or Life/Technical Sciences as well as a high level of expertise and practice in conducting audits.
- We are looking to recruit a person with substantial practical experience in quality assurance within an R&D or Operations environment such as Pharmaceuticals, Medical Devices
- Excellent working knowledge and understanding of GxP-related requirements, including proficiency in US regulations (FDA) and ICH guidelines, is required.
- Other desirable assets include strong written and oral communication skills and an ability to be independent and self-disciplined, allowing for timely audit report submission and follow up.
- Fluency in both written and spoken English is a must; proficiency in French would be an asset.
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