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QC Lab Manager Nörten-Hardenberg Germany,  

DFE Pharma (company)

Posted on : 27 April 2017

Project Description

Job description
  • You will develop and implement efficient, cross-functional solutions for driving Quality Control throughout the development and commercialization lifecycle. 
  • A significant responsibility of this position is to keep performance at a high quality standard to support submissions and inspections.
  •  Lead the Quality Control to oversee regulatory compliance to company standards.  
  •  Pro-actively work with Supply Chain and Manufacturing to assure product supply commitments are met.    

  • Ensuring that the QC lab complies to industry standard (IPEC, USP/EP/JP excipient chapters) and regulatory requirements 
  • Ensure product compliance to standards guaranteed, release testing and stability testing with-in set time frames 
  • Group management of the QC laboratory team; planning, organizing, effective delegation of responsibilities of the team , coaching & developing, talent development and daily occurrences 
  • Create an environment of continuous improvement to ensure execution of analysis in the most reliable an efficient way 
  • Guide the laboratory in a changing environment, in which in-process controls become more and more important 
  • Advising customers on analytical and microbiological questions related to our excipients 
  • Cross-functional advise and trouble-shooting on analytical and microbiological problems 
  • Advise, development, validation and transfer of (new) test methods 
  • Responsible for ensuring quality of environmental monitoring and IPC at the site
  • Responsible for the validation (status) of analytical and microbiological methods and equipment 
  • Accompany internal and external audits and responsible for adequate and timely response to observations 
  • Adequate application of order, tidiness, hygiene and safety regulations according to established code of conduct 


Candidate profile
  • BSc/MSc in chemistry or similar, microbiological education is preferred 
  • Experience in method development and validation 
  • Experience in managing a QC lab and product release testing 
  • Experience with SAP or similar and managing the end to end process together with other disciplines 
  • Effective communication skills 
  • Proven ability to manage multiple tasks simultaneously whilst maintaining and reporting overview and maintaining a high level of accuracy in all work carried out 
  • Experience in GMP environment and pharmaceutical quality systems, preferably excipients 
  • Written and spoken English and German language skills are preferred 

Job conditions
  • We offer a highly dynamic and energetic work environment full of ambitious international growth opportunities and continuous learning, with an excellent remuneration package. 
  • We consider it important for our people to continue to grow. 
  • After all, your development is not only good for your career; we also benefit from it. 
  • That s why we invest in relevant personal development. 
  • The mutual exchange of knowledge between colleagues is also evident on the work floor.
  •  It is, after all, the most effective way to learn.


Nörten Hardenberg Germany

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