QC Supervisor

Région
Mont-Saint-Guibert (Commune), Nivelles
Publication
mardi 5 juin 2018
Date limite
vendredi 20 juillet 2018
Type de contrat
CDI
Temps de travail
Temps plein

NOVADIP-BIOSCIENCES is an innovative biotech company, based in the Walloon Region (Mont-Saint-Guibert), with a strong expertise in the development of novel regenerative medicines. This human-sized structure is a leader in first-in-class treatments for hard and soft tissues.

If you are sharing the vision of developing life-improving and life-saving products and if you are looking for new challenges amongst a dynamic and innovative team, consider collaboration with this fast growing company.

In order to support this exciting development, we are looking  for a (m/f) :

 

                                         QC Supervisor

 

Responsabilities

As a QC Supervisor, you will be in charge of operational activities related to quality control assays of the Novadip’s experimental products. 

This position requires a rigorous, well-organized, meticulous and conscientious person with excellent ability to work in team.

Your main responsibilities are as follows:

  • Ensure that appropriate tests are carried out on all production batches of Novadip Biosciences non-commercial investigational products (development, technical and clinical batches)
  • Ensure that the analyses done are compliant with the regulatory framework rules and regulations and with Novadip Biosciences quality system procedures
  • Ensure that Novadip Biosciences products, including starting materials and raw materials, are only released if their quality meets specifications
  • Assist the Head of QC with the general organisation of the activities, including the management of human resources
  • Support the Head of QC to establish, validate and implement quality control procedures to be used for release and characterisation testing assays and to ensure the timely signing off of analysis files
  • Participate in the design of experiments, taking account of current pharmaceutical developments and respecting the international standards and regulations to be met in the pharmaceutical industry, especially for ATMPs
  • Assist with the management of documents relating to quality control (specifications, procedures, protocols, sampling methods, validation and the archiving of files) 
  • Act as a technical advisor to the QC team and respect GMP, GCP and GLP principles and guidelines
  • Monitor internal QC activities: planning, review and validation of file data, analyses and interpretation of results, writing reports (clinical batches, stability, development, analysis of raw materials), initiation of OOS and deviation investigations
  • Participate in the writing, revision, validation and /or approval of analysis reports
  • Monitor outsourced analyses: planning, follow-up, review and validation of analysis reports
  • Supervise and periodically verify the cleaning/tidiness of the QC laboratories and the completion of related checklists, including equipment logbooks
  • Write general quality system procedures to underpin company objectives, and to be in compliance with the regulatory requirements for QC activities
  • Carry out any other tasks required to ensure the continuity of the quality control process

Profile

  • Master Degree in Biotechnology/Biology or equivalent relevant experience.
  • At least 5 years of relevant experience in a GMP environment in an equivalent position.
  • Strong theoretical knowledge in cellular biology, molecular biology and biochemistry
  • Strong knowledge in method development and validation
  • Practical experience in cell culture (stem cells), immunoassays (ELISA, Flow cytometry, immunohistochemistry), bioassay, PCR, microbiology is a strong asset
  • Flexible, concerned about the quality of work and respectful of planning.
  • Good knowledge of Microsoft Word and Excel.
  • Ability to work in a team and collaboratively in a matrix organization (R&D, QC, QA, RA).
  • Excellent oral and written communication skills in French, and ideally also in English
  • A diversified full-time permanent position within a high-potential innovative biotech company.
  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.

Offer

  • A diversified full-time permanent position within a high-potential innovative biotech company.
  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.

Interested?

Please  send  your  CV  to  careers@novadip.com. Your application and related information will remain strictly confidential.  

 

 

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