QA Manager for QC Oversight and Change Management

vor 1 Woche

Darmstadt, Deutschland Steigerwald Arzneim. GmbH Vollzeit

 

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 Manager for QC Oversight and Change Management (all Genders)) 

 

YOUR TASKS AND RESPONSIBILITIES

In the area of QA Oversight Quality Control:

  • You will be responsible for securing QA monitoring for the validation of analytical methods
  • You will ensure the regulatory requirements and their implementation in the laboratory area
  • Review and approval of SOPs and quality control qualification documents
  • Review and approve deviations, out-of-specification (OOS), CAPAs, and quality control changes
  • Review and approval of the validation master plan of the quality control laboratories
  • You will represent quality assurance in cross-functional teams and projects

 

In the field of change management:

You will provide support in coordinating approval and implementation of change projects across the site

 

WHO YOU ARE 

We are excited about your talent and passion for this position. Attracting the right talent is important to us. We would be happy to work with you to identify and create the career and development opportunities you are looking for - also in part time. And if you don't meet all the requirements, we still look  forward to receiving your application. We are all constantlylearning

 

  • You have a university degree in a natural sciences degree program Ideally
  • You have several years of professional experience in the GMP-regulated area, preferably in a role in the field of quality
  • You have an experienced handling of the Dev@Com and Synaps systems, which will be an advantage for you
  • You have a high degree of accuracy in dealing with national and international regulations (GMP, ICH, EMA)
  • You have excellent communication and analytical skills as well as a high level of quality awareness, proactivity and reliability
  • You have good (cross-functional) teamwork skills
  • You have very good written and spoken German and English skills 

 

The position is limited to 9 months as a parental leave replacement.

 

Be You. Be Bayer.
#LI-AMSEMEA

 

 

 

Location:

Germany : Hessen : Darmstadt  

 

Division:

Consumer Health 

 

Reference Code:

819629 

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