QA Validation Specialist

Posted 16 Jul 2019

Tiburtina, Lazio - Italy

Req Id 194607

Details

 

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


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.

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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