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Senior Associate Quality Control, Raw Material Solothurn Switzerland,
Posted on : 10 July 2017
- We are building a new, Next-Generation Biologic Manufacturing Facility with high throughput production capacity.
- Rapid identification technologies, such as Raman spectroscopy and XRF (X-Ray Fluorescence) will be instrumental in reducing the time required onsite to complete confirmation identity testing of each lot of material received.
- The facility will utilize new technologies pioneered by our experts in technical development and employ an innovative, world-class engineering design to deliver substantially increased productivity. As a Quality Analytical Raw Materials Associate you will strongly and effectively contribute this exciting project.
As Senior Associate, you will be responsible for Raw Material Release within the Quality department, which includes:
- Strongly support the implementation of the raw material strategy based on rapid spectroscopic methods as a technical expert - validation and technology transfer and provide the GMP-conform documentation, Support the state-of-art status of techniques
- Generate specification rational reports, align with raw material vendor specifications, improve GMP documentation process
- Support the GMP-conform implementation of the raw material work flow with business execution systems like Oracle, LIMS and support the continuance; Support the implementation of electronical analytical data transfer from vendors to our company (eData)
- Provide troubleshooting support for instruments, support maintenance of lab systems to ensure integrity of all analytical results
- Ensure execution of investigations in case of rapid identity failing, author investigational protocols, investigational reports, change control requests and validation/qualification protocols
- Provide troubleshooting on rapid methods for warehouse personnel, provide quality input to warehouse related activities
- Minimum of five years experience in regulated (bio)pharmaceutical QC environments, raw material QC experience is a plus
- Strong analytical skills with high knowledge of implementing analytical techniques into regulated GMP areas, proven technical leadership as a subject matter expert within the responsibilities
- Demonstrated problem solving skills, ability to multi-task operations, working autonomously and cross-functional
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness
- Fluent in German with a high level of English to be able to generate and review technical reports, SOPs and work stream papers
- The opportunity to join a world-class company and participate in building up a next generation biopharmaceutical facility
- A permanent contract with superior compensation, sustainable learning and great development opportunities in a fast paced multicultural environment.
42 h full time
Bachelor degree in Chemistry, Biology or related Life Science discipline, an additional apprenticeship degree is a plus
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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