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Quality Assurance Expert, Automation & Sterilization Qualification

Posted 16 Jul 2018

Corsier-sur-Vevey, Vaud - Switzerland

Req Id 179222

Details

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


An exciting new opportunity has arisen to join us as Quality Assurance Expert for our Biotech drug substance plant in Corsier s/ Vevey.

As an integral member of the Quality Unit, you provide QA expertise for the Automation Systems validation and Sterilization/Sanitization qualification. The role consists to elaborate the Sterilization/Sanitization qualification strategies, review and approval of Automation work order (WO), participates to risk analysis, identifies gap and purposes remediation plan. You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics. You review and/or approve qualification documents (equipment, automation), risk assessment, SOPs and take quality decisions according to company standards.

The activities of the QA Expert cover all qualification phases from Basic Design until 1st use of equipment/software. You ensure GMP compliance during all phases of qualification/validation.

Who you are:

  • University or relevant engineering degree 
  • Hands on experience of equipment Qualification/Automation Systems/Sterilization&Sanitization 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
  • Knowledge in CSV and Data Integrity will be a plus
  • Experience in Equipment (Production/QC equipment)
  • Good interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changes
  • Good writing skills.
  • French & English written & spoken.

What we offer: 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!

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