Qualified Person
vor 2 Monaten
For our client in the field of pharmaceutical analysis we are looking for a Qualified Person (m/f/d) at the Hamburg site.
If you are a team player and interested in multifaceted, challenging tasks, we look forward to receiving your application. Become part of our innovative and dynamic team and help us shape the future of the company. The position is limited to 2 years.
Randstad Professional welcomes applications from all people. We do not discriminate on the basis of religion, origin, gender, sexual orientation, age, marital status or physical characteristics.
Here's what our clients offer
an open corporate culture with flat hierarchies and plenty of creative freedom an international corporate environment Attractive remuneration with profit-sharing Flexible working hours 30 days vacation entitlement plus additional days off Employer-financed company pension scheme Team events... and much more
Your tasks
Implementation and further development of a corporate QM system Responsibility for and ensuring the implementation of all official audits, including contract manufacturers and suppliers Management and organization of the Quality Management Circle (QMC) Ensuring that all processes, systems and functions comply with the applicable legal requirements and industry standards in close cooperation with the "AMWHV responsible persons" Ensuring all cGMP-compliant quality agreements with customers and service providers Fulfilling the responsibilities of the Qualified Person according to §14 AMG: Checking the compliance of the manufacturing and/or testing with the rules of cGMP according to the EC GMP guidelines, the recognized state of science and technology as well as the pharmaceutical rules of the legislation (AMG/AMWHV) and the requirements from the valid delimitation of responsibility contracts. Authorization to place medicinal products and clinical trial samples on the market according to a written procedure (or rejection if necessary) Written confirmation, with date and personal signature, of manufacture and testing in compliance with the approval of the clinical trial and the GMP rules according to the current state of knowledge and technology. Maintenance of a continuous release register in accordance with § 19 AMG and 17 (5) AMWHV with certification before placing on the market Providing information to the competent authority as part of the duty to cooperate in accordance with § 66 AMG Responsibility for and ensuring the processing of complaints
Your profile
License to practice as a pharmacist University degree in pharmacy with several years of professional experience in the areas of production, quality control and quality management Qualification as a Qualified Person according to § 15 AMG Previous professional experience as a Qualified Person is an advantage Sound knowledge of cGMP guidelines Language requirements: German, English (written and spoken)-
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