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QC Scientist Neuchâtel Switzerland,  

Shire (company)


Posted on : 27 October 2018

Project Description

shire is the leading global Biotechnology company focused on serving people with rare diseases and other highly specialized conditions. we strive to develop best-in-class products, many of which are available in more than 100 countries, across core Therapeutic Areas including Hematology, Immunology, Neuroscience, ophthalmic, lysosomal storage disorders, gastrointestinal/Internal medicine/endocrine and hereditary angioedema; and a growing franchise in oncology. in 2016, shire grew its organization to approximately 24,000 employees+ globally, following integrations of dyax and baxalta.

an exciting and challenging opportunity has become available at shire neuchâtel plant (approx. 650 employees) for a qc Scientist.

this is an exciting Career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Control teams within a world-class biotech GMP Manufacturing environment.

job summary

the job holder is accountable for life cycle management activities of analytical Assays performed in the qc laboratories of neuchâtel – switzerland with a focus on Laboratory investigations. in addition, the job holder also leads Laboratory method validations, transfers, improvement projects and supports complex multi-sites investigations.

                                                                                                         

essential duties and responsabilities

  • comply with GMP requirements and applicable qc procedures
  • identify and facilitate/lead Problem-solving and improvement projects using dmaic approach
  • investigation Owner and Coordinator (out-of-specification, out-of-limit, and out-of-trend analytical results, and other types of investigations)
  • responsible for writing validation protocols and reports for Analytical methods
  • responsible for writing Qualification plans and reports for critical reagents and reference standards
  • oversee validation and Qualification activities executed by local qc, provide Training and support
  • support of analytical method transfers as transferring or receiving unit between r&d and analytical laboratories as well as within Operations
  • write assignment plans and reports for method controls, establish and perform evaluation of control charts
  • support and preparation of audits, audit responses and regulatory submissions
  • participate in multi-site projects as local project lead, working in collaboration with other scientists from global qc and analytical development groups

Education & experience

qualifications

living our Leadership behaviors is a basic expectation for all shire employees. shire expects all employees to embody the following:

  • be positive
  • be accountable
  • be results oriented
  • be an excellent manager of self and others

Locations

, Neuchatel, , CH

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