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.
- 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.