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QC Analyst

Dfepharma_english - Wageningen - 02-10-2019 Naar vacature  

(02/10/2019 2:26 AM)
Discipline
Supply Chain - Make
Requisition ID
2019-37465
We are on a pursuit of excipient excellence, through which we want to help people live healthier lives. Over time, we have developed from a pioneer organisation into a global one with currently over 400 employees. This demands great entrepreneurial power and leadership in everything we do.

We are looking for people who take ownership, are not afraid for accountability, deliver and who dare to make mistakes and learn from them. Working at DFE Pharma means having the freedom to act, the craving to take responsibility, developing your skills, and working within a motivated cross-functional team in an international playing field.

 
To be able to keep up our high industry quality standards we decided to bring all the lab activities into one location and to create a new QC Analytical Chemistry laboratory. During this challenging and exciting project, a lot of preparations are needed (e.g. designing processes, qualifying equipment and test methods and acquiring new staff). Now it is your chance to join and help to establish the new QC lab!

Your impact in a new team

What will your new team look like?
You will be part of the Quality Control department and will report to the QC manager
You will start to work in a team of 5.5 FTE and the team will significantly grow in the near future
Where will you be working?
New QC laboratory at Novio Tech campus in Nijmegen (The Netherlands)
Incidentally you will visit our production locations in The Netherlands or Germany
What does success look like?
Built an efficient state-of-the- art analytical chemistry laboratory
Successfully comply to the industry standard (IPEC and USP-NF, Ph. Eur, JP excipient chapters)
Transfer all internal and external lab activities correct and in time to the new QC analytical chemistry laboratory
In time release of batches within the set lead times
Be a reliable and knowledgeable business partner for our customers
Execution and reporting of stability studies

How will you make an impact? The main responsibilities are:
As a QC Analyst, you will be responsible for the correct execution of physical and chemical analysis according to the sampling and analysis instructions

Execute analysis according to the highest pharmaceutical quality standards and cGMP/GcLP standards
Ensure proper functioning of analysis equipment by performing regular calibration, maintenance and first line trouble shooting
Execute validations according to validation protocols
Work closely together with R&D and Manufacturing to assure product development and supply commitments are met and to support in-process controls (e.g. trainings) and continuous improvements

Work closely with the local and corporate QA teams to start investigations in case of deviations and Out-Of-Specs

Your profile and our rewards


We are looking for candidates (with):
Who like to work in the start-up and transfer phase of the new laboratory
MLO / HLO (BSc) in chemistry or similar
Experience in a QC lab and product release testing
Knowledge in GMP environment or ISO 17025 and pharmaceutical quality systems, preferably excipients
A high level of accuracy
Experience with SAP, LIMS or similar and manage the end to end process together with other disciplines
Experience in method development and validation are preferred
Fluent in English

We offer:
We offer a highly dynamic and energetic work environment full of ambitious international growth opportunities and continuous learning, with an excellent remuneration package. We like open communication and short decision lines. 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. If you like to work in an environment with flat hierarchy, you are at the right place at DFE Pharma. Our team is passionate and willing to make things happen, as together we are striving for excipient excellence.

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