Contract: Quality Control Technician III / North Holland
|Location:||Haarlem, North Holland|
The client are currently recruiting a Quality Control Technician III Inhalation Capsule drug products, based in the North of Holland.
Essential Duties and Responsibilities:
* Routine Testing of the raw materials, primary and printed packaging materials & finished products, stability samples, and in-process control samples according to SOP and as per the committed timelines.
* Handle quality management system like Deviations, Out of specification results (Phase 1 investigation), Out of trend results instability as well as in released products,
* Writing, review and approval of test results
* Maintain adherence to corporate policies and appropriate regulations through actions and decisions
* Active participation in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions
* First-line Troubleshooting of laboratory equipment
* Active participation in changes or act as change owner as a part of continuous improvement.
* Work a 5 shift pattern (24/7) might be an option
* Bachelor degree in analytical chemistry/pharmacy or equivalent experience
* Knowledge and familiarity with the use of Pharmacopoeia methods
* A strong analytical oriented mindset.
* Experience with working in a pharmaceutical environment
* Experience with development/validation or verification of analytical methods for complex drug products like liposomal or protein-coated drugs
* Experience with analytical techniques like UPLC/HPLC, TOC, PSD, etc.
* Good knowledge of Pharmaceutical quality systems and production processes
* Experience & exposure to work in the regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVlSA
* Team player
* Strong can-do mentality