Analytical Expert

CordenPharma Brussels
Brussels, BE
Full-time

CordenPharma Brussels

Brussels, BE
Full-time

Founded in 1987, Corden Pharma Brussels was a member of the Solvay group until being acquired by CordenPharma in October 2013. Peptisyntha has built more than 30 years track record of success in supplying pharmaceutical and biotech companies with small to commercial scale cGMP peptide API manufacturing using world-class cost-effective production processes. Through expertise and capabilities in all synthetic manufacturing technologies, Corden Pharma Brussels assesses and customized their manufacturing approach to achieve the most effective manufacturing process for their customers.

Corden Pharma Brussels has developed a portfolio of innovative proprietary technologies with the objective to shorten synthetic processes / reduce the number of steps, control quality, and simplify (or eliminate) HPLC purifications for short peptides.

Function description

The analytical expert will be working as part of the Quality control department ensuring raw data are reliable in accordance with cGMP.

He / she will be responsible for ensuring timely, accurate completion of QC testing performed both in house and at vendors.

In addition, the analytical expert provides training regarding people and follow the daily activities for ensuring the consistency of the results.

The analytical expert is reporting to the QC manager of Corden Pharma Brussels.

Main activities

    • >> Ensuring follow-up of day-to-day activities, supervising implementation and progress of the QC activities (staff support, coaching and training)
    • >> Managing SOPs, change controls, deviations, OOS and CAPA
    • >> Ensuring smooth running of the lab: on-time & GMP-compliant analyses; housekeeping of the lab
    • >> Develop and/or review departmental documentation including test methods, SOP’s, protocols and reports ensuring compliance with cGMP and applicable regulatory guidelines
    • >> Validation of Analytical methods : need to be able to set up and write validation protocol , to analyze the validation results and provide conclusion , to release the validation report
    • >> Implementing and validating the new analytical methods after development phase done by R&D team (write validation protocol, analyze the validation results and provide conclusion )
    • >> Stability studies management and results interpretation
    • >> Review and Approval of analytical dossier
    • >> Contact with external customers for QC related issues
    • >> QC Release of raw materials, intermediates products and finish product
    • >> Technical support during customer audit and regulatory inspections (FDA, AFMPS, other)
    • >> Coordinate laboratory equipment acquisition, qualification, calibration and preventative maintenance.
    • >> Leading QC optimization processes and Operational Excellence QC project
    • >> Ensuring good relationship with internal and external stakeholders

    Challenges du poste:

    • >> Instaurer une culture de sécurité dans l’entreprise : en impliquant l’ensemble du personnel dans une démarche participative. Ce volet demande la sensibilisation du facteur humain aux enjeux de la sécurité
    • >> Mettre en place/mise à jour des analyses des risques notamment les risques chimiques
    • >> Conduire l’entreprise dans un projet de certification OSHASS 18001, ce qui représente une preuve pour les clients que la sécurité est intégrée dans le processus de gestion de l’entreprise

    Minimum experience required:

    • >> 3-5 years in a similar role in the pharmaceutical industry (API is an asset)

    Qualifications:

    • >> University degree in a scientific discipline with analytical background is mandatory (Chemistry is an asset)
    • >> Language requirements: English (written and spoken), French

    Specific competences required:

    • >> Strong laboratory skills and strong knowledge of analytical chemistry (HPLC, UHPLC, GC,……………)
    • >> Very good knowledge of cGMP in a regulated environment (US and Eur)
    • >> People management experience (Leadership experience)
    • >> Strong problems solving skills, issue resolution and root cause analysis
    • >> Experience with guidelines , standards (ICH, Pharmacopea, 21CFR part 11)
    • >> Experience with regulatory inspection (FDA and AFMPS)
    • >> Proven ability in prioritizing according to the needs
    • >> Strong quality and service minded
    • >> Customer oriented, team player, focused on improvement
    • >> Excellent interpersonal skills
    • >> Working knowledge of computer packages (Word, Excel, MS Project, Visio, Power Point)
    • >> Able to work independently in a fast paced multitasking environment.

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