QA-systems Specialist - Berlin, Deutschland - Bayer

Bayer
Bayer
Geprüftes Unternehmen
Berlin, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter


Beschreibung

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

QA-Systems Specialist (M/F/d)

YOUR TASKS AND RESPONSIBILITIES

  • Local Business Administrator (LBA) for PH External Manufacturing GMP IT systems
  • Work as 1st level support (M/F/d) to the GxP systems and grant user access rights
  • Work to ensure operational lifecycle management of the EM GxP systems including change management, obsoletion, archiving and periodic
system review processes to ensure e-Compliance with Bayer and health authority requirements

  • Administrate the onboarding of employees to ensure complaint documentation handling, regular update of training matrix and curricula in MyLearning
system

  • Carry out administrative activities for the release of EM internal work instructions and SOP's in eDMS (LifeDoc) and ensure the appropriate document
workflow and maintenance in eDMS

  • Key Administrative Officer (M/F/d) for quality systems duties and responsibilities, building and maintaining internal digital tools as well as organizing the
logistics for internal and external audits and inspections

  • Data provider for weekly, monthly and quarterly KPI's tracked by quality systems and used for quality management reviews
  • Carry out oversight of EM paper and electronic archiving (inventory, appropriate registration, record traceability, cleaning and final disposition) of GMP
documents and records to meet ALCOA+ and data integrity principles


WHO YOU ARE

  • Bachelor's degree in business administration, economics, computer or natural sciences
  • Several years of professional experience in the GxP field
  • Indepth knowledge of quality management systems/cGMP and ISO standards
  • Proficiency in MS Office (MS Excel and MS Word in particular) and good knowledge of eDMS, SAP and other data basis/repository GxP systems
  • Good cooperation skills and strong organizational skills with the ability to multitask
  • Teamplayer (M/F/d) with a sense of urgency and good communication skills as well as the ability to achieve results even under tough circumstances
  • Fluent in English, both written and spoken

This is a fixed-term contract for 24 months.

Applications from employees in Germany who may be affected by personnel reduction will be treated favourably.

YOUR APPLICATION


This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change.

You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.


Location:
Germany : Berlin : Berlin || Germany : North Rhine Westfalia : Leverkusen || Switzerland : Basel-City : Basel


Division:
Pharmaceuticals


Reference Code:735881

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