Quality Assurance & Regulatory Affairs Officer

Louvain-la-Neuve, à 30 km au sud de Bruxelles
lundi 19 février 2018
Date limite
jeudi 5 avril 2018
QARA Officer Feb 2018.
Type de contrat
Temps de travail
Temps plein

The Minafin group of fine chemical companies develops and produces active pharmaceutical ingredients (APIs) as well as advanced intermediates for the pharmaceutical, cosmetic and green chemistry industries. Structured by brand, the group has been supporting its customers for many years in the scale-up and development of their products, with an emphasis on safety requirements and high quality standards. Thanks to its network of manufacturing sites in Europe and the US, the group has realized sales of EUR 180 M with over 800 employees.

Minakem High Potent with its site at Louvain-La-Neuve, Belgium is developing and producing highly potent APIs and controlled substances according to cGMP and is currently looking for a

Quality Assurance & Regulatory Affairs Officer
in a GMP environment


After your training period, you become QA&RA responsible for the generic portfolio of Minakem High Potent and perform the following tasks:

▪ You review and approve process and analytical documents for the release of intermediates and final drug substances, including coordination of investigations and final approval of all modifications during the manufacturing process from raw materials to finished product: process & analytical changes and deviations, nonconformities, customer complaints….
▪ You are responsible for the submission and maintenance of Minakem High Potent Regulatory Files to European, US and other Health Authorities
▪ You define and ensure follow-up of actions for continuous process improvement and customer requests in collaboration with the project team. You draw up the Annual Products reviews for final active substances (API’s)
▪ You elaborate the process validation documentation, as part of the project team
▪ You take part to the Quality audits performed by Health Authorities and Customers and to the definition and implementation of corrective actions
▪ You act as contact person for the different internal departments such as Quality Control, Production, R&D, Sales, and for the Customers
▪ You participate to the maintenance of the Quality system (management of procedures, internal audits, supplier audits,…)
▪ In this function, you report to the QA &RA Manager


▪ You have an university degree in chemistry, biochemistry, pharmacy (Master, Bio-engineer, Engineer, Ph.D.)
▪ A first relevant experience in Quality Assurance and / or Regulatory Affairs in a Pharmaceutical environment as well as knowledge of GMP and Regulatory guidelines is an asset.
▪ You have a good knowledge of chemical processes, organic synthesis and statistical process control tools
▪ An excellent knowledge of French and English (spoken and written) is a must
▪ You have a very good knowledge of MS Office.
▪ You are able to tackle complex problems with logical mind and to develop practical & quality oriented strategies for improvement.
▪ On the one hand, you like to communicate in a constructive way to induce quality mindset. On the other, you have affinities for administrative work. You are a good writer and your reports are comprehensive and precise.
▪ You can work in a team as well as autonomously


Interested? Please send your complete application to joblln@minakem.com, mentioning job code QARA Officer Feb 2018.

Minakem High Potent
8 rus Fonds Jean Pâques
1435 Mont-Saint-Guibert

Visit www.minafin.com

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