Quality Control Specialist II

2 weeks ago

Ljubljana, Ljubljana, Slovenia Lek, a Sandoz company Full time €40,000 - €60,000 per year

Be part of an exceptional story in Brnik (Slovenia) We're establishing a state-of-the-art center for the production of sterile biosimilar medicines, powered by the latest technology to deliver high-quality, affordable biosimilar medicines to patients worldwide. Join the team that's shaping the future of pharmaceuticals—today.

Responsibilities

  • Implementation of a new analytical technique for testing medical devices (autoinjectors).
  • Manage OOx / analytical deviations and complaints.
  • Ensure all activities in compliance with cGxP, and with data integrity. Perform Quality Control (QC) oversight activities.
  • Maintain and calibrate equipment including plan preparation.
  • Review and approval of analytical tests (analytical release), materials and product.
  • Interpretation and reporting of results and analysis of trends.
  • Participation within the validation, transfer and management of issues related to analytical methods and techniques in accordance with requirements.
  • Responsible for the creation and revision of standard operating procedures (SOPs), Certificate of analysis (CoA), analytical and registration documentation
  • Support laboratory associates in their daily tasks and troubleshooting.

Qualifications

  • University degree in pharmacy, chemistry or any other natural science degree.
  • Preferred experience in production, development or other quality functions on expert position.
  • Knowledge of English.
  • Knowledge of Microsoft Office.

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