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Senior Validation Manager - Sweden  

Company managed [?] Still accepting applications

Posted on : 10 July 2017

Project Description

Description:
 We are looking for a senior validation manager with GMP and regulatory know-how and experience to our office.


Background: 
As a senior validation manager, you have background of MSc/BSC chemical/biochemical engineering or MSc Pharmacy or similar Experience; you have worked more than 10 years in the Pharmaceutical field, and at least 5 years in Validation Management. Mandatory experience:  
  •  Process work within pharmaceutical / biotech manufacturing  
  •  Commissioning and qualification management and execution for complex pharmaceutical manufacturing equipment  
  •  Risk Assessment for pharmaceutical production (CQA, CPP, SIA and Control strategy)  
  •  Validation Management for Process Validation  
  •  GAMP5-experience   

    
Preferred experience:  
  •  Regulatory filing of Quality data/module 3  
  •  Experience from working with or Building Quality Management Systems  
  •  Qualified Person Accreditation  
  •  Cleaning Validation experience  
  •  Laboratory equipment/method validation experience    
  

Mandatory skills: 
  •  Fluent in Swedish and English  
  •  Business oriented  
  •  Able to travel 1 - 2 weeks every second month