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Quality Assurance Engineer

Your role: An exciting new opportunity has arisen to join us as Quality Assurance Engineer for our Biotech drug products plant in Aubonne.

As an integral member of the Quality Unit, you provide QA expertise for a new Aseptic Filling and QC Laboratory facility project. The role consists in support design and qualifications activities for Facilities, Equipment and Utilities in the frame of site projects. You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics as part of this new facility project. You review and/or approve design specifications, layouts, qualification documents, SOPs and take quality decisions according to company standards. This major project is expected to last for the next 5 years and will deliver a next generation manufacturing platform for our fill and finish network.

The activities of the QA Specialist cover all project phases from Basic Design until 1st GMP production in several years. You ensure GMP compliance during Design, Selection, Commissioning and Qualification.

 

Who you are:

  • University or relevant engineering degree 
  • Hands on experience of qualification/validation in the pharmaceutical industry
  • At least 5 years’ experience in a quality environment in pharmaceutical industry or equivalent
  • Knowledge in cGMP and health authority expectations
  • Experience in Equipment (aseptic fill and finish, isolator technology and support equipment) and qualification
  • Experience in tech transfert & quality by design
  • Able to address the latest cGMP requirements in engineering projects for sterile drug products.
  • Good writing skills, French & English written & spoken.
Job Requisition ID:  191242
Location:  Aubonne
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Biotech, QA, Quality Assurance, Pharmaceutical, Quality, Science, Technology

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