Please refer to JobSuchmaschine in your application
Switzerland, Basel-Town, Basel
As the Senior Quality Manager Chemicals - Direct Material Specification Lifecycle Management you are part of the Direct Material Specification Lifecycle Team.
This team plays a decisive role in the deployment and realization of the quality strategy of Direct Material (DM) specification lifecycle management for Pharma Global Technical Operations. The team is responsible for the development, implementation and life cycle management of DM specifications, the management of processes for Direct Material lifecycle management of specifications, and implementation and realization of the quality strategy for globally managed Transmissible Spongiform Encephalopathy (TSE) / Bovine Spongiform Encephalopathy (BSE) and Genetically Modified Organisms (GMO) services for Pharma Technical Operations (PT).
As the Senior Quality Manager of chemical materials you ensure that the risks for the “right to operate” and “quality supply” of products to our patients are minimized. You are responsible for ensuring that all global specifications including starting materials, intermediates, excipients, process aids, standard chemicals and purchased API’s comply with global regulations, industry standards and Roche’s high standards of quality of materials across sites globally.
In collaboration with all other PT functions, regions and sites, you are responsible for the development of global specifications including risk assessments by means of proactive risk management tools and approaches. In addition, you will be responsible for the end to end execution and planning process of specifications from development to retire across Roche sites (local and global sites) and External Quality Operations CMO.
Your tasks and responsibilities will include:
This position is located in Basel, Switzerland.
You have a B.A. or B.S. degree (preferably in chemistry or chemical engineering) with at least 5 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience. You bring working knowledge of GxP (GLP, GCP, GMP), FDA Guidelines and Points to Consider documents, applicable local and international regulations, and standards routinely used in the industry (Q7, ANSI, ISO, Federal Standards, IPEC, etc.). You bring detailed knowledge of drug product material manufacturing processes, laboratory test methods to include EP, USP, JP and ChP requirements and industry standards.
In addition you bring the following qualifications:
This position may require up to 10-15% national and international travel.
Please apply until: 12 November 2017.