International Pharmaceutical Company (Noord Holland)
You will be working in 5 shifts (weekends included). Work pattern for 24/7 m/m/e/e/n/n/ followed by 4 days off. You are going to be a part of production site involved in the production of Inhalation Capsule drug.
- 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 time lines.
- Handle quality management system like Deviations, Out of specification results
- Writing, review and approval of test results
- Active participation in advanced problem solving, root cause analysis, troubleshooting...
- Active participation in changes or act as change owner as part of continuous improvement.
- 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 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 regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVlSA
Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.