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QA Computer System and Validation Expert

Your Role

Within the scope of a challenging, ambitious and future-oriented project driven by a dynamic team in an inspiring environment you will elaborate the computerized systems quality strategy including all aspects of data integrity. You will participate in risk assessments, collaborate with the Computerized systems and equipment validation project teams ensuring that all the deliverables meet quality specifications, and review and approval of GxP documents (including URS, traceability matrix, risk assessments, systems drawing, procedures, qualification and validation documents). You will also perform supplier audits, if necessary. You will also participate to health authority inspection.

 

Who you are

  • Minimum bachelor’s degree in computerized systems and equipment validation
  • At least 5 years of experience in a pharmaceutical/biotechnology environment
  • Knowledge in biotechnology process, cGMP, and health authority expectations
  • Knowledge in GAMP and CSV regulations
  • Knowledge of equipment validation standards
  • Show a desire and motivation to work in Quality and project environment
  • Have a proactive approach to all aspects of Quality
  • Good communicator, dealing directly and efficiently with project teams and global Healthcare Quality Organization
  • Strong analytical and problem-solving abilities
  • Organized and logical in defining workload and delivering projects
  • Fluent in English (written and spoken)
  • French is an advantage
Job Requisition ID:  207339
Location:  Corsier-sur-Vevey
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

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.

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