Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of biologics to protect people worldwide from immunological diseases.
As a Qualified Person (QP) you will ensure that drug substances are manufactured and distributed according guidelines, and ensure its release.
- - Reviews and approves release (including non-conformances and test results) of Drug Substance lots manufactured. This includes process validation batches and commercial batches.
- - Reviews critical quality documents (e.g. Annual Product Reviews en Continuous Process Verification reports).
- - Ensure safety, efficacy, and quality of product released
- - Approval of High Risk (Global) Changes Controls. Represent site in the local change control board.
- - Act as EU-QP in other site escalation boards.
- - Manage the Quality escalation and communication of issues that exceed the scope of a single site.
- - Provides support during internal/Partner audits and inspections by Health Agencies and acts as SME regarding quality oversight of drug substance production process and Qualified Person’s role and responsibilities.
- - Partner in the Executive Management Review.
- - Master’s degree in Biochemistry, Biology, Pharmaceutical degree or relevant education. Acted as QP in the Pharmaceutical industry.
- - Proven knowledge of the biotechnological/pharmaceutical industry and at least 6 years of experience in a GMP regulated environment (manufacturing, QA, and/or QC)
- - You have excellent proficiency in English and Dutch both in word and in writing.
- - Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
For more information please contact Guilherme Tokunaga at email@example.com or +31 (0) 20 658 98 01.