Qualification and Validation Manager (AP)

Qualification and Validation Manager (AP)

#18825187 | 30 January, 2018
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Location
Geneva, Geneva, Switzerland
Type of position
Permanent
Required years of experience
2 to 5 years
Required languages
Educational requirements
Required skills
Categories
Industrial IT Engineer Other
Description

We are currently looking on behalf of one of our important clients for a Qualification and Validation Manager. This role is permanent position based in Geneva

 

Your role:

  • Responsible to maintain our global Validation Master Plan including: Equipments, Utilities, and Premises Qualification, Computer System Validation, Process Validation
  • To establish risk assessment and to coordinate Change Control activities mainly for technical and quality aspects for Equipments, Utilities and Premises.
  • Oversees validation of production processes, performs statistical analysis, develops validation models, and writes process validation protocols and final packages.
  • Serves as liaison/team member with technical and production departments
  • Review and develop standard operating procedures in compliance with Good Manufacturing Practice (GMP)

 

Your skills :

  • First and successful experience with validation and qualification activities. Aseptic manufacturing knowledge is preferred.
  • Hands on with aseptic filling equipment and facilities, autoclaves, lab test equipment, HVAC and WFI systems is preferred
  • Good knowledge of GMP (US and Europe)
  • Working knowledge of Computer Validation and of statistics as related to process control.
  • Working understanding of Risk Analysis and Control
  • Experience with Deviations and CAPA management system (eg: Trackwise), Documentation Management system, MES and SAP 

 

Your profile :

  • Technical Degree from a University, Engineering School or equivalent in Life Sciences Excellent soft skills
  • Fluency in English and French is required for the role 

 

If you wish to apply, please send us your resume in Word format with some references

Contact Anthony Patus : ap@helvetica-partners.com

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