Roche Diagnostics in Rotkreuz (ZG), the world leader in in-vitro diagnostics, is looking for a motivated team player with experience in test equipment qualification and test method validation in a GMP-regulated manufacturing company
Product Quality Planner (a)
Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.
As a Product Quality Planner, you are responsible for the planning and state of the art measurement of the technical test specications. This role assures that the products are tested compliant to the regulations, including statistical sampling plan and test procedures. The Product Quality Planner provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.
Your tasks
* Transfer product specication into test equipment requirements (URS)
* Dene and develop test equipment
* Dene acceptance criteria for test equipment
* Accountable for creation of test plan
* Implementation of test planning at supplier and RDI
* Dene sample size for in-process control (IPC), product release testing and incoming goods inspection
* Conduct internal and supplier trainings regarding product quality inspection
* Accountable for test equipment qualication, test method validation, including correlation studies to RDI test equipment
* Technical Q&V documentation review at supplier regarding test equipment qualication, test method validation
* Responsible for review of rst article inspection (FAI) incl. verication of the tolerance situation
* Technical assessment of changes of test equipment and test planning
Your qualifications
* M.Sc. or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
* 3+ years of relevant work experience in a GMP regulated, producing company
* Experience in IVD product manufacturing and testing, and with in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.
* Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
* Experienced in test equipment qualication and test method validation
* Excellent communication skills in German and English
* Ability to think strategically and systemically, willingness to try new ideas and participate in changes
* Self-motivated, autonomous, structured and goal-oriented mindset with a solution oriented balance of short term mitigation and long term solution
* Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport
* Travel required up to 10% (global incl. USA ad China)
Your application
Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)
Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.
Branche: Pharma-Industrie
Funktion: Ingenieurwesen/Planung
Anstellungsart: Befristeter Vertrag
Karrierestufe: Angestellte/r