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QC Lab Manager - 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 DFE Pharma quality standards.   Pro-actively work with Supply Chain and Manufacturing to assure product supply commitments are met.    You are responsible for the management of all Nörten-Hardenberg QC activities related to products produced by DFE Pharma. This includes: 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 Nörten Hardenberg site Responsible for the validation (status) of analytical and microbiological methods and equip-ment 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 Comply with all company SHE regulations and contribute to a proactive SHE culture. 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 op-portunities 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.

Locations

Nörten Hardenberg Germany

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