EU Qualified Person
The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release. Primarily, this position will be responsible for release of clinical product in accordance with the requirements of EC/2001/83, EC/2001/20 and Annex 16 and 13 requirements. The QP may also release commercial product (product for sale or supply in the EU or for export) in compliance with the regulations.
The Qualified Person performs the QP responsibilities to ensure compliance with GxPs, Seagen procedures and national regulations.
The Qualified Person (QP) is responsible for ensuring 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.
- 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
- Verify that each batch of medicinal product is distributed under conditions that meet the GDP guidelines
- Release or reject unlabeled Drug Product and Finished Drug Product
- Maintain a register (or equivalent document) as a record of product batches certified by Qualified Person prior to release
- Ensure the expiry date complies with the approved shelf life
- Continuously improve and maintain the Quality System to remain in compliance with the applicable GMP/GDP regulations and local requirements
- Provide support to improvements of the Quality System documentation system to ensure the system remains current
- Participate in external audit program including follow-up activities (if applicable)
- Provide QP support and ensure the appropriate cGMP and/or study documents, deviations, OOS/OOT, change control, CAPA, etc. have been approved
- Assist in regulatory or other inspections
- Execute responsibilities to certify the Supply Chain
- Issue QP Declarations for sites that are certified to meet GMP requirements
- Participate in risk assessment, decision-making, communication and risk reducing action related to defective product
- Perform regulatory reporting and product withdrawal/recall for the EU Market
- 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)
- Actual 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
- Completion of a university course of study in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology or a course recognized as equivalent by the Member state
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.