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Supervisor Quality Control, Logistics/Sample Management Solothurn Switzerland,
Posted on : 04 July 2017
- Our company is building a new, Next-Generation Biologic Manufacturing Facility with high throughput production capacity.
- Rapid testing methodologies in combination with highly efficient testing strategy and sample management will be instrumental in reducing the time required onsite to complete analysis for in-process and Drug Substance testing.
- 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.
- To help us setting-up this project we are looking for a Supervisor Quality Control Logistics/Sample Management.
Job Purpose and Responsibilities
The Supervisor Quality Control Logistic/Sample Management will implement all sample management activities and support the execution of the analytical capability strategy, which includes:
- Recruitment and build-up of the Sample Management team
- Create and manage the process for retain samples (raw material and drug substance)
- Management of laboratory autoclave and glass washing
- Management of stability samples
- Support all start-up activities for the new lab, e.g. definition and implementation of workflows and issuing standard operation procedures
- Intra-site sample and test solution logistics as well as lab reagent ordering, management and distribution.
- These samples include in-process samples as well as monitoring samples for the EM and UM programs.
- Support the facility certification and establishment of the environmental (EM) and utility monitoring (UM) program for the site.
- Author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.) according cGMP requirements and regulatory requirements.
- Drive activities at the site to adhere to the construction or operational schedule
- Alignment of best practices, interpretation of regulatory standards and test execution is strongly valued within company s Global Quality Control network
- Minimum of 6 years of experience in regulated (bio)pharmaceutical quality control environments
- Prior experience within a GMP Quality Control function and ideally minimum of 2 years of experience in managing a team.
- Proficiency with the Quality systems and business processes associated with Microbiology testing (drug substance)
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.)
- Prior experience with facility construction and start-up strongly preferred.
- Strong problem solving skills, ability to multi-task operations, working autonomously and cross-functional
- Demonstrated ability to work autonomously and to lead project teams
- Project experience would be a plus
- Very good command of German and English
- 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
- 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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