Arbeitsbeschreibung - QP / Qualified Person / Sachkundige Person (m/w/d) Heidenheim a. d. Brenz/Berlin/remote
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 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.
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.
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