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QA Validation Specialist

Your role:

You will be part of the Quality Assurance team, reporting to QA System Manager, in a plant focused on New Biological Entities and New Chemical Entities development activities. You will contribute to an effective Quality System management to support site activities, in all phases of product Development, Clinical Trial Production and Quality Control activities, interacting with multifunctional working groups. You will provide specific expertise on Equipment Qualification, Computerized System Validation and Data Integrity. You will support the informatic tools management used to handle Quality System flows, assuring their effectiveness and performing quality indicators monitoring and trend analysis. You will be asked to promote change and innovation to achieve continuous improvement, with a strong focus on fundamentals.

 

 

Who you are:

  • Degree in Chemistry, Biotechnology, Biology, Pharmaceutical Chemistry, or equivalent.
  • Fluent in written and spoken English.
  • At least 4/6 years of experience on pharmaceutical Quality System management with focus on analytical equipment and facilities/utilities qualification, computerized system validation and Data Integrity
  • Deep knowledge of cGMP guidelines and their application, with focus on Change Management and Deviations Investigation; Lean Management concepts and Risk Management tools knowledge will be considered as a plus
  • Good interpersonal skills, ability to communicate, negotiate and interact constructively with colleagues and other functions, within a matrix context. Strive for results, team working, problem solving and customer orientation attitude.
Job Requisition ID:  194607
Location:  Tiburtina
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: Developer, Biotech, Product Development, Pharmaceutical, QA, Technology, Science, Research, Quality

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