Senior Validation Specialist

Vor 2 Tagen


Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit
Company Overview

Gi Group SA is a global HR services and consulting company that supports the development of the labour market and helps to change people's lives in 37 countries around the world.

About Gi Life Sciences

We are a specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.

Your Mission

The Validation Senior Scientist will be responsible for ensuring that products/processes meet regulatory requirements and quality standards. This position regularly works cross functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors.

Key Responsibilities:
  • Develop, implement and manage the site process validation strategies to meet cGMP and quality requirements on time and on budget.
  • Collaborate with cross functional teams to define the interfaces to equipment qualification, system qualification and analytical method validation.
  • Establish and maintain the Validation Master Plan for process validation.
  • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach.
Requirements
  • Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science
  • Minimum 4-6 years of experience in pharmaceutical industry with MSc degree or 7-9 years' experience with BSc (GMP validation experience is considered an asset)
  • Strong problem-solving skills, strong verbal and written communication skills
  • Excellent command of English and preferably French language
Estimated Salary

$80,000 - $110,000 per annum, depending on experience.



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