QA Validation Specialist

What are your responsibilities?

  • Perform QA support and oversight for equipment, automation and IS validation. This function does not develop the technical solutions. 
  • The QA validation specialist will work under supervision of qualified staff on site. Level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc) 
  • Expectation is that staff can perform selected QA validation activities within one month from starting date. 
  • Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met. 
  • Maintain a close contact and familiarity with local Quality systems 
  • Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures. 

Who are we looking for?

  • University or Bachelor degree in Pharmaceutical sciences, Process Technology, Engineering or equivalent 
  • 3 years of professional experience in GMP environment 
  • Relevant experience in Equipment and Automation Validation 
  • Additional experience with Non Conformances, CAPA’s and Change Control 
  • Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11). 
  • Good attention to detail and excellent writing skills 
  • Effective communication skills at multiple levels and areas (inside and outside of Quality) 
  • Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc. 
  • Problem Solving 
  • Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. 
  • Works under minimal direction 
  • Work is guided by operational and project objectives 
  • Manages multiple assignments and processes 
  • Independently determines approach to project

What does QbD offer you?

  • A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package

Interested? Apply now by sending us your CV and motivation.