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Sr Associate I, Quality Assurance Solothurn Switzerland,
Posted on : 19 June 2017
- The Quality Engineering Senior Associate I 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 high level project groups as appropriate and be an active member of groups/project teams in which Quality input is needed. These projects are expected to be cross-functional in nature and may involve participation across sites as well. The Quality Engineering (QE) Senior Associate I is responsible for the oversight of key functional, tactical and operational aspects within the Quality Assurance organization at the company Facility.
- This will require the integration of technical knowledge in one or more areas (Engineering, Manufacturing, Automation, Quality Control Testing) with compliance/regulatory expectations.
- QE Senior Associate I may support Quality Engineering management for activities related to interviewing, hiring and training of employees, as well as compliance with training policies and may be granted authority to sign for the Area management on GMP documentation at the direction of the QE management, including the approval of investigations within the deviation system.
- For the first year may need to travel up to 50%.
- Author, review and approve moderately complex GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) requiring the ability to grasp and apply regulatory and compliance knowledge from multiple markets/agencies with limited support.
- Interact with Regulatory agencies directly during audits as well as providing input into such documents as regulatory filings.
- Proactively identifies and resolves technical and compliance issues/gaps.
- Provide support to multiple areas within and between facilities; requiring a high level of regulatory and company Quality and Process system knowledge
- Identify gaps, revise/develop and implement Quality systems that can be global in scope with limited supervision
- 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.)
- Act as primary Quality Engineering interface for change control activities - may involve authoring/reviewing/approving change controls
- Maintain knowledge of relevant FDA/EMA regulations and compliance.
- Approximately 6 plus years of experience in pharmaceutical or biotech manufacturing environment.
- Prior experience with regulatory audits
- At least 3 years of 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 oriented 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 and influence without authority across the organization with limited supervision.
Bachelor s Degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Computer Science Engineering
- 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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