Senior Quality Assurance Professional

Category: Quality

Location:Kalundborg, Region Zealand, DK

• QA approval, review, and oversight of various documents and processes related to the daily operation of an assembly and packaging facility in Kalundborg.

• Review of batch documentation, product release, approval of deviations, change requests, trend reports, SOPs, etc.

• Presence on the shop floor in production as a consultant to address real-time issues and improve and simplify processes.

• Ensure high product quality and compliance with current GMP rules and guidelines.

• Contribute to setting the direction for quality at FPM DK-1 KA as a senior professional, ensuring the highest quality for patients in a changing and challenging environment.

• Participation and data presentation at internal audits and external authority inspections.
  
  

• A degree in Pharmacy, Veterinary Medicine, or a related field, ensuring compliance with the Danish Medicine Agency's requirements for the "Qualified Person" role.

• Extensive experience in the pharmaceutical industry, with a preference for a minimum of 3 years in quality assurance and/or production.

• Ambitious and prepared to contribute to our continual efforts to improve our high standards.

• Willingness to challenge existing practices and take initiative while being accountable for personal learning.

• Demonstrated role modelling of suitable behaviour.

• A dedicated team player who inspires trust and respect among colleagues and partners.

• Exceptional collaboration and communication skills due to our extensive collaboration with various stakeholders.

• Proficiency in both English and Danish, given the international nature of our company, is essential for this position.