This job is currently Archived,
Posted on : 27 April 2017
- 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
- 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
- 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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