QP / Qualified Person in the Pharmaceutical Industry (m/f/x) – Heidenheim a. d. Brenz/Berlin/remote

THE FORCE CT GmbH; Heidenheim an der Brenz, Berlin, Hamburg; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in the pharmaceutical sector is seeking a Qualified Person to oversee compliance with German regulations and EU GMP guidelines. This role involves monitoring production/testing processes, managing narcotics responsibilities, and collaborating with authorities. If you have a pharmacy background and seek a dynamic environment, join us to make an impactful contribution!

Qualifikationen

• Professional experience in the pharmaceutical industry in production or testing.
• Ideally experience as a responsible person in the field of narcotics.

Aufgaben

• Perform responsibilities of a Qualified Person in accordance with German Medicines Act.
• Monitor EU GMP status and manufacturing/testing of medicinal products.
• Handle tasks of the responsible person for narcotics.

Kenntnisse

Analytical thinking

Problem-solving skills

Fluency in English

Fluency in German

Ausbildung

Completed studies in pharmacy

Qualification as a Qualified Person

Jobbeschreibung

GENERAL INFORMATION

Tired of being a solitary bird? Join our team and share your wisdom!

Location: one of our offices in Heidenheim an der Brenz/Berlin (Germany) or remote
Starting: at the next possible date

YOUR PROFILE

THE FEATHERS IN YOUR CAP:

• Successfully completed studies in pharmacy
• Qualification as a Qualified Person according to § 15 AMG and recognition as a Qualified Person by a state authority
• Professional experience in the pharmaceutical industry in the production or testing of pharmaceuticals
• Ideally experience as a responsible person in the field of narcotics

WE DON’T EXPECT YOU TO BE AS WISE AS AN OWL, BUT YOUR WISDOM INCLUDES:

• Strong analytical thinking and problem-solving skills
• You don’t get your feathers ruffled when it comes to taking on tasks that aren’t directly related to your position because your team needs your help.
• Your fluency in both English and German allow you to chirp away and successfully communicate with the team.

YOUR TASKS

YOU SWOOP DOWN ON YOUR QP DUTIES FOR US AND OUR CUSTOMERS IN A NOSEDIVE:

• You perform the responsibility of a Qualified Person (QP) in accordance with §14 of the German Medicines Act (AMG).
• You monitor EU GMP status as well as manufacturing and testing of medicinal products – all with an eagle’s eye on the respective guidelines such as the marketing authorization, the AMG, AMWHV, and the EU GMP Guidelines.
• With your keen vision, you take care of market releases of batches before they’re placed on the market, maintenance of the ongoing release register and annual preparation of PQRs.
• You handle the tasks of the responsible person for narcotics.
• You dig your talons into the approval of qualification and validation measures.
• You carry out internal and external audits with vigilance.
• You act as a contact person for authorities and customers.
• Your advice and support in all pharmaceutical and drug law related issues gives wing to your colleagues and customers.

NO MATTER IF EARLY BIRD OR NIGHT OWL:
You are flexible in your working hours, your location, and your work itself. You will also have a big say in what exactly you and we are aiming for. But above all, we are interested in you as a person and focus on your specific talents.
We are looking for that certain something – and will give it to you in return. Odd bird, crazy goose, or wise owl? We welcome birds of all feathers!

All of this sounds as you could take to it like a duck to water? Contact us to find out if we can flock together and send your application via our application form.