One of our favorite biotechnology clients has a job opening for a EU Qualified Person in Amsterdam.
- Ensure that each GMP batch for a clinical trial is produced and analyzed in accordance with cGMP guidelines and European directives 2001/83/EC, regulation 536/2014 as amended, the Quality Assurance Agreements, the Product Specification File (PSF), and the information submitted in Clinical Trial Authorization
- Ensure that commercial GMP batches are produced and analyzed in accordance with the cGMP guidelines and European directives 2001/83/EC, the Quality Assurance Agreements and the Marketing Authorization
- The release of clinical product in accordance with the requirements of EC/2001/83, EC/2001/20 and Annex 16 and 13 requirements.
- The release of commercial product (product for sale or supply in the EU or for export).
- Ensure that, prior to the certification of any given batch of drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.
- Verify that each batch of medicinal product is distributed under conditions that meet the GDP guidelines.
- University degree in relevant field
- Qualification requirements as laid down in the Directive 2001/83/EC and the following directives:
- EU Directive 2003/94/EC (GMP for medicinal products for human use)
- The Rules Governing Medicinal Product in the European Community, Volume 4: Medicinal products for human and veterinary use: Good Manufacturing Practices
- (Bio) Pharmaceutical background
- Fluent in English (written and spoken)
- Up-to-date knowledge of GMP and other applicable regulatory requirements
- In depth knowledge and experience with quality systems, corrective action and preventative action system, statistical process control, risk management, FMEA and other key tools for managing quality performance
- In depth knowledge of validation (assay validation, computer validation, process validation)
- At least 1 year of relevant experience in a pharmaceutical setting, in case of having completed full university course of pharmacy (6yrs) For other completed university studies, at least 2 years of relevant experience in a pharmaceutical setting are applicable
ORGANISATION AND OFFER
This biotech company is committed to advancing late-stage clinical trials and expanding the development of its portfolio to better the health of people with cancer. They are dedicated to improving patient outcomes through advanced antibody-drug conjugate technology designed to deliver cell-killing agents directly to tumor cells. They are focused on discovering, developing and commercializing a new generation of transformative cancer medicines and empowered antibody-based therapies that have the potential to change the foundation of treatment for people with cancer.
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme? Check this LINK
For more information, please contact Ralph Looijen on +31 (0)20 20 44 502