QC – Supervisor (1 year fixed-term contract)
Wavre, Walloon Brabant, Belgium
6 dagen geleden

In order to reinforce our team, we are looking for a QC Supervisor for a 1 year contract.

Key responsibilities :

You participate in adequate validation / qualification (design and follow-up of execution) of (in-process) analytical methods using appropriate statistical tools, in line with projects timelines

You participate in the analytical methods transfer from ARD and to other quality control departments

You write technical documents (SOPs, validation protocols and reports)

You ensure (in-process) analytical support to process scale-up, to industrialization bulks and formulation groups, to process evaluation and validation and ensures the testing of development and phase 3 clinical lots

You assist the QC product coordinator by providing all analytical relevant information generated in his / her team

You are a representant of his / her activities in internal teams (ex : staff, transfer meetings)

You guarantee the compliance to cGMP / QA rules in his / her laboratory team (SOP, Documentation, Audits, training, method validation)

You participate in deviations management in his / her laboratory team

You ensure contact and collaboration with maintenance, QA, R&D, RA, production, QCss, purchasing, ...

You proactively propose testing improvement in the frame of his / her laboratory

You share know-how with others (Coaches technicians and assures their evolution) in his / her competency domain and proactively supports others to develop

You participate in the replies to auditor’s requests during inspections

You gather information requested by RA

Why you?

Basic Qualifications :

We are looking for professionals with these required skills to achieve our goals :

Master's in sciences linked to Microbiology / Biotechnology / Vaccines development (Bioengineer, University's degree in Microbiology, Biology, Biotechnology, Pharmacology, .

  • or equivalent experience acquired though professional experience.
  • 2 to 3 years of experience in similar function in the pharmaceutical or biological sector

    Demonstrated practical knowledge and competency in in general microbiology and associated pharma industry testing (Detection of Bioburden, Sterility test, Disinfectant efficacy, Detection of Mycoplasma, ) with a focus on the endotoxin test and LER effect

    Fluent in French and good level of spoken and written English beyond scientific English

    cGMP and regulatory constraints knowledge

    Rigorous, proactive, organized, resilient, autonomous

    Ability to work on several projects / subjects in the same time

    Preferred Qualifications :

    If you have the following characteristics, it would be a plus :

    PhD is a plus

    Good knowledge in microbiology test validation principles. Rapid Microbiology methods is a plus

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