Qualified Person

Proclinical is seeking an Experienced QP who can contribute to raising the quality systems needed for the preparation of life-saving medicines to the next level. This role will be based in Amsterdam on a permanent basis.

The Qualified Person within the QA department is responsible for the release of these products according to applicable guidelines. An important responsibility that you share with a number of fellow QP colleagues. You report directly to the Vice President Quality.

Job Responsibilties:

• The release of end products that comply with the granted permits and current laws and regulations;
• Monitor and take joint responsibility for the quality systems;
• Preparing, modifying and / or assessing the required documentation (SOPs);
• Evaluating whether procedures comply with applicable laws and regulations in collaboration with other disciplines and departments;
• Making an active contribution to quality improvements and process optimization;
• Maintaining the system for possible recalls and the handling of post-donation reports in accordance with internal procedures;
• Co-ordinate the policy to assess the quality of products and / or production processes as well as payroll contracts, contract laboratories and suppliers;
• Maintaining contacts with OMCLs, contract partners and relevant inspection authorities.
• You will work on the Quality unit.
• This department consists of Quality Assurance, Quality Control, Validation and Release. The QP is part of the Release group.
• The Quality unit consists of approximately 200 people.

Skills and Requirements:

• Completed Master's degree in chemistry, (micro-) biology, biotechnology, pharmacy with pharmacist's diploma (or equivalent);
• At least 5 years of work experience as a certified QP in the (bio) pharmaceutical industry;
• Experience with the functional management of employees;
• Knowledge of cGMP and GDP guidelines (from both the European Union and the Food and Drug Administration);
• Experience with the implementation of quality improvements;
• Monitoring, analysing and assessing developments in the field on consequences and / or usability for the organization;
• The ability to respond flexibly to new developments and changing priorities;
• Good communication skills, both orally and in writing in the Dutch and English language.
• Accurate, stress-resistant and collaborative.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.