Pharmaceutical Quality Assurance Chemist

6 days ago


Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time

FUJIFILM Diosynth Biotechnologies is a world-leading Contract Development Manufacturing Organization (CDMO) providing services to the pharmaceutical industry. Our mission is to 'Advance Tomorrow's Medicines.'

The company offers a dynamic and collaborative work environment with opportunities for professional growth and development.

We are seeking a skilled chemist to join our Quality Control Chemistry department at our Hillerød site. The successful candidate will be responsible for ensuring the quality of commercial products and collaborating with cross-functional teams to achieve this goal.

Key Responsibilities:

  • Scientific responsibility for assays performed in QC Chemistry, including testing, improvement, troubleshooting, and investigation in compliance with cGMP.
  • Laboratory support for unexpected analytical method trends.
  • Daily QC manager approval of test results for commercial products.
  • Handling deviations, invalid assays, laboratory exceptions, CAPAs, and Change Controls.
  • Collaboration with the Analytical Development department on transferring new methods for testing in QC laboratories.
  • Implementation of new instruments in collaboration with the QC Instrument supporting team.
  • Authoring technical protocols and reports for qualification and analytical improvement projects.
  • Ensuring compliance with cGMP and participating in audits and inspections.

Requirements:

  • A Master's degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or a related field.
  • Knowledge of GMP and quality systems.
  • Experience with various chemistry methods, including compendial and HPLC/CE-SDS/cIEF testing.
  • Method validation, qualification, and troubleshooting experience related to DS and DP.

We offer a competitive compensation package and excellent benefits. If you are a motivated and detail-oriented chemist looking for a challenging role in a fast-paced environment, please submit your application.



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