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Associate III, Quality Assurance Solothurn Switzerland,
Posted on : 17 April 2017
- The Quality Engineering Associate III is responsible for supporting the company Quality Management System on review and approval of validation and engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where Quality Assurance needs to approve before implementation and upon completion.
- Furthermore, this role can participate in project groups as appropriate and be an active member of groups/project teams in which Quality input is needed.
- These projects may be cross-functional in nature and might involve participation across sites as well.
- The Quality Engineering (QE) Associate III is responsible for the oversight of key functional, tactical and operational aspects within the Quality Assurance organization at the company.
- This will require the integration of solid technical knowledge in one or more areas (Engineering, Manufacturing, Automation, Quality Control Testing) with compliance/regulatory expectations related to the Quality Engineering function.
- QE Associate III may support Quality Engineering management for activities related to interviewing, hiring and training of employees, as well as compliance with training policies. For the first year may need to travel up to 50%.
- Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) related to technical areas (Manufacturing, QC Testing, Engineering, Maintenance, Metrology or Automation - Delta V, Syncade, etc.)
- Provide support to areas within the facility and may participate on projects across sites; requiring a good working knowledge of regulatory and company Quality and Process systems as well as working knowledge of technical areas (Manufacturing, QC Testing, Engineering, Maintenance, Metrology or Automation - Delta V, Syncade, etc.)
- Work alongside more senior members of the Quality Engineering Team to revise/develop and implement complex Quality systems that can be global in scope.
- Ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)
- Performs Quality review and approval of change control documents and activities associated with change control
- Maintain knowledge of relevant FDA/EMA regulations and compliance.
- Approximately 4 years of experience in pharmaceutical or biotech manufacturing environment.
- Previous experience within Quality Assurance or related function is preferred.
- Good communication skills in English, verbally and written. Dual language is preferred with a preference for German and English.
- Technically orinented role including experience of the validation of laboratory, production equipment automation systems and knowledge of production methodology involved in biopharmaceutical production.
- Self driven, demonstrated ownership and responsibility for work assignments.
- Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work with colleagues across the organization.
Bachelor s Degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer Science
- Our company is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases.
- Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
- Founded in 1978, our company is one of the world s oldest independent biotechnology company.
- Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options.
- These include programs for secondary progressive MS, Alzheimer s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.
- With more than 7,500 people worldwide, our company is truly a global organization.
- Our international operations are based in Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark.
- We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
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