QC – method validation professional
What are your responsibilities?
You will be responsible for (analytical) method validation process validation to ensure compliance with regulatory expectations and consistency with current industry practice.
- Monitor and assess new developments, industry trends, evolving regulatory expectations in the analytical method validation field
- Support QC analytical method validation improvement programs
- Establish and maintain current knowledge of global regulations, regulatory expectations, inspection intelligence and industry standards
- Ensure compliance with external and internal requirements
- Define the product requirements and contribute to the development of policies and standards
- Work with a network of local experts and ensure sharing of best-practice and learnings
- Monitor and analyse assessment criteria on the system performance (incl. trend analysis, effectiveness evaluation
Who are we looking for?
- You possess a master degree in Sciences: chemistry, microbiology, biological sciences, pharmaceutical science, bio- or chemical engineering or related field
- You have at least 4 years of experience in Biologicals or Pharmaceutical Industry and have proven experience within (analytical) method validation
- You are familiar with GMP/GLP and international regulations and guidelines
- You are familiar with analytical techniques like HPLC, PCR, GC, …
- You have an analytical mind and are able to translate complex processes into clear, efficient and compliant procedures
- You have a good knowledge of quality and risk management principles and tools
- You are an excellent communicator in Dutch and English (spoken and written)
- You organise your work efficiently and know how to deal with pressure and deadlines
- You possess good IT-skills (eg Outlook, Word, Excel, Powerpoint,â€¦)
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.