Gxp Specialist - Ettlingen, Deutschland - Bruker

Bruker

Geprüftes Unternehmen

Ettlingen, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Présentation:

Bruker Corporation's companies belong to the world's leading analytical and measuring instrumentation manufacturers in the sector of life sciences.

For the last 60+ years, Bruker has been fulfilling one single purpose:
to deliver the best technological solution. Today, more than 7,500 employees worldwide are working on this challenge, in over 90 locations in all continents.

Bruker BioSpin, as part of the Bruker Group, is a high-tech international company and the world-leading manufacturer of comprehensive solutions in Nuclear Magnetic Resonance (NMR), Electron Paramagnetic Resonance (EPR) and Preclinical Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Positron Emission Tomography (PET) as well as Magnetic Particle Imaging (MPI).

We develop high-tech analytical measuring instruments and methods that are used in many fields, from medical technology to materials science and food research.

In addition to being the market leader in most of our product and service groups, we want to make sure that you are doing well to focus on the tasks at hand.

To this end, we offer you:

A canteen with meal vouchers
Job bike
Hybrid working possibilities
Support for your pension scheme
Capitalforming benefits
30 days of vacation
Modern airconditioned buildings
Stateoftheart office space & infrastructure
Free employee parking
Highly satisfied and forward striving teams
Talented and diverse employees from and all over the world
Finally, of course, the fact that even though we are listed on the stock exchange, we are still safe and sound in the hands of our owner and thus able to weather all storms.

For our office in Ettlingen or Faellanden we are searching a

GxP Specialist

(M/F/d).

Does this sound great to you?

Responsabilités:
This role comes with a variety of responsibilities, but also with freedom in your day-2-day work.

Team member in a team of 5 Regulatory Affairs professionals, positioned in several countries, with Production Sites close to Zurich CH, Karlsruhe GER and Strasbourg FR (some travel required; remote work option with 2 days out of 5 home office)
Good practices (GxP) compliance rollout in an international analytical instrumentation life sciences company from identification/achievement of URS and creation of DQ/IQ/OQ documentation to daytoday support of internal and external stakeholders (e.g., on FDA 21CFRpart11 req.), GxP experience with/on reagents/consumables a plus
Ensure international good practices in a proactive and pragmatic, but always compliant way

Does this sound interesting to you?

Qualifications:

Academic degree in a relevant field
Proven multiyear experience in the life sciences industry (e.g., Pharma) in the field of quality and/or regulatory affairs on good practices
Proven project management skills, international and crosscountry exposure a plus
Fluent in English including presentation and trainer skills, German and/or French a plus
Ability to interact and align with various stakeholders from board level to peer groups
Strong track record in prioritizing and simultaneously managing and/or supporting multiple GxPrelated projects in a fastpaced environment

You love GxP?
**Then get started today - we are keen getting to know you