Quality Assurance Officer

What are your responsibilities?

  • Responsible for providing advice, support and approval during root cause investigation,corrective/preventive actions and change control of procedures and processes. 
  • Reviews and approves standard production documentation and protocols and can act as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes. 
  • Timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures. 
  • Acts as a subject matter expert for GMP compliance during root cause investigations, change control procedures and improvement activities and approves final protocols and reports. 
  • Ensures correct administration and documentation of data in accordance with guidelines and local procedures. 
  • Advocates safety culture within the organization. 
  • Indicates opportunities for improvement and takes part in projects in order to implement changes.  
  • Reviews and approves changes and associated documentation (i.e. change control, qualification/validation) 
  • Monitors activities concerning compliance and ensures validated status of GMP processes and systems. Ensures that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date. 
  • Advises the production departments regarding GxP compliance. 
  • Ensures on time resolution deviation investigations. 
  • Reviews and approves deviation investigations. 
  • Participates in internal and external audits and projects as required. 
  • Supports local training initiatives (i.e. development of training modules, actual training of individuals). 
  • Supports (improvement) projects.

Who are we looking for?

  • Higher education degree in a Life Sciences related field (HBO or Msc) 
  • At least 3 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and/or audits 
  • Knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and non-routine cases 
  • Knowledge of manufacturing processes and operations. 
  • Strong communication skills, both written and oral. 
  • Business proficient knowledge of Dutch and English language. 
  • Self-motivated and the ability to motivate others. 
  • Strong organizational skills and ability to manage multi tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail). 
  • Strong safety awareness. Able to identify potential safety risks and take responsibility in addressing the risks. 
  • Demonstrated ability to work as both a team player and independently. 
  • Skill in evaluating operations according to company and regulatory guidelines (policies, processes, procedures). 
  • Pragmatism 
  • Ability to make decisions in a highly complex environment that balance business needs, quality and compliance risk and other constrains. 
  • Ability to manage and distribute workloads. 
  • Ability to provide direction and support goalsetting for individual staff members and work groups (planning/prioritizing/goal setting). 
  • Drive for improvement 
  • Out of the box thinker, able to manage ambiguity. 
  • Resilience 
  • Ability to manage diversity and conflicting viewpoints.

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.