Quality Control

What are your responsibilities?

You are responsible for the quality control operations: support the manufacturing operations through microbiological and chemical tests, develop and validate analytical methods linked to equipment validation, accountable for aseptic and environmental monitoring performance and manage QC projects.

Responsibilities:

  • Manage QC tests to support commercial manufacturing
  • Coordinate and/or perform QC checks and remediation actions specified in Annual Quality Plan. Monitor progress and effectiveness of remediation actions
  • You actively contribute to the establishment and implementation of lab compliance related CAPAs resulting from audit observations (external and internal) or from adverse events (e.g. deviations)
  • You provide support in case of audits (internal and customer audits) and inspections for health authorities
  • Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation
  • Participate in root cause analysis; lead and write laboratory investigations
  • Investigate laboratory quality issues and recommend sound corrective actions and resolution
  • Perform and review equipment calibration and maintenance; instrument advocate and subject matter expert
  • Manage complex technical and/or production problems, evaluate potential impact on product quality and escalate to management
  • Ensure quality systems (deviation, OOS investigation, CAPA, documentation, training, chance control, validation activities, maintenance and calibration activities) are in place/in use and handled in a timely manner
  • Communicate quality control information to all relevant organizational departments, outside vendors, or contractors

Who are we looking for?

  • You possess a master degree in sciences (micriobiology, bio engineering, biotechnology, pharmacology, …) or equivalent through experience
  • You have at least 3 years professional experience in the pharmaceutical/biotech/medical device industry including QC related experience
  • 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 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,…)

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.