Job Description

Consultys Benelux is looking for a Quality Validation Lead with a minimum of 5 years experience in the Biopharma sector.

A Quality Validation Engineer will be needed to review all the Validation documents related to different CAPEX projects

• Equipment modification project
• Purification/Process/Cleaning projects
• Packaging projects if needed
  
  

The Quality Validation Engineer gives the Quality oversight in the different validation strategies that are discussed, and then review and approve all the validation documents in a Quality perspective.

Your Main Responsibilities

• Review/approval of validation documentation from projects (RA, DQ, IQ, OQ, PQ, PPQ) and associated specification documents (URS, Functional/ Design Specification)
• Provide quality guidance for the development strategy and risk analysis related to the validation
• Provide support in quality-related issues, including GMP regulations
• Ensure the compliance with internal SOPs, and all aspects of safe
  
  

Required Profile

About you :

• You have a Scientific or Engineering Background (minimum a Master)
• You have minimum 5 years in Quality Validation, or 5 years in Validation with some other experience in Quality (Quality mindset)
• You have main expertise in Process Validation, Cleaning Validation, Equipment Validation, with understanding of the automation part of the equipment.
• Nice-to-have: expertise in CSV, Data Integrity
• Knowledge of Validation and Engineering functions.
• You know GMPs regulations
• You are a leadership
• Strong oral and written communication skills
• Teamwork skills.
• You develop and maintain good working relationships with customer groups
• Critical thinking and demonstrated problem solving skills.
• Good Organizational skills
• We need someone with assertivity skills, autonomous, self-motivated
  
  

Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.