Hobson Prior is seeking a Qualified Person to join our team. This role focuses on ensuring the quality of medicinal products and investigational medicinal products. The successful candidate will be responsible for the release of bulk goods, ensuring compliance with relevant regulations, and maintaining the quality management system. This role requires a strong communicator and team player with a structured and responsible way of working.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

For this role, you will approve medicinal products and investigational medicinal products per Section 14 AMG Paragraph 1.
Release bulk goods from external contract manufacturing companies for further processing.
Ensure compliance and implementation of requirements from the Medicines Act, AMWHV and EC GMP guidelines.
Take personal responsibility for the market release of medicines.
Support the head of quality control in pharmaceutical law issues as an expert person.
Handle, document and process deviations, cause analyses and change control processes.
Act as a contact person for complaints from authorities and participate in the investigation of drug complaints.
Ensure that approved medicinal products are manufactured and tested per the requirements laid down in the approval.
Review and approve change control procedures and PQRs (periodic quality reviews of medicinal products).
Organize and continuously improve the quality management system, taking business aspects into account.
Represent the surveillance authorities.
Ensure compliance and monitoring of all GMP and legal quality requirements for all product categories.
Check pharmaceutical contracts: e.g. Quality agreements and responsibility delimitation contracts.
Collaborate technically in the new and further development of drugs and formulations.
Ensure stability tests and monitor product stability.

Requirements

Pharmacist or corresponding qualification or recognition.
Expertise according to § 15 AMG.
High sense of quality and responsibility as well as a solution- and results-oriented approach.
Entrepreneurial and cross-functional mindset.
Confident use of MS Office.
Strong communicator, and team player with a structured and responsible way of working.
Fluent in spoken and written English.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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