gmp compliance

☞ Randstad

전망: 145

갱신일: 08-12-2025

위치: Wavre Walloon Brabant

범주: IT-소프트웨어 IT-하드웨어 / 네트워킹 정보 기술 마케팅 / 홍보

산업:

직업 종류: Freelance

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작업 내용

job details

summary

  • wavre
  • contract
  • 40 hours per week
  • group function
    technics
  • reference
    CXRSP-108457
job details

We are looking for a GMP compliance support for one of our clients in Wavre.

Don’t hesitate to contact me: isabelle.guilmot@professionals.randstad.be

...

We are looking for a GMP compliance support for one of our clients in Wavre.

Don’t hesitate to contact me: isabelle.guilmot@professionals.randstad.be

  • key responsibilities

    The principal duty of the Site Conformance expert is :

    • To ensure as quality representative, compliance to regulatory dossier of activities related to Manufacturing Performance Units or Quality Control Department
    • To ensure the regulatory oversight within Manufacturing Performance Units or Quality Control Department.


    Your responsibilities:

    • Review and/or approval of variations/submissions/RTQ/Commitment + provide technical support to GRA
    • You support Manufacturing Performance Units or Quality Control Department for CMC processes
    • On quality oversight of source documents and providing operational documents to support GRA in authoring post approval changes’ variations
    • Review, on behalf of Operations, submitted documents to Health Authorities in the frame of Regulatory Submission Process.
    • Support Questions & Answers and Commitments process within Manufacturing Performance Units or Quality Control Department.
    • Support QA and MPU head in the prioritization of the CMC subjects in their area
    • You oversee Change Control
    • You provide technical support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities in the frame of post approval changes management.
    • You provide CMC and regulatory conformance expertise to support release of products in compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.


  • qualifications

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

    • Scientific background
    • Knowledge of legislation related to license acquiring and post approval changes management
    • Knowledge of the CMC dossier and GMP
    • Technical understanding of product manufacturing processes and/or testing
    • Good knowledge in English
    • Sense of urgency, flexibility and accountability Enterprise thinking (cross functional team spirit)
    • Strong quality and results oriented mindset
    • Assertive
    • Lean culture spirit
    • Ability to work across boundaries
    • Good communication skills

    The following characteristics it would be a plus:

    • Demonstrated ability to quickly understand end to end process
    • Demonstrated ability to take full accountability of small or medium project
    • Good analytical and problem-solving skills

  • key benefits

    Consultancy

    We offer an attractive salary with extra-legal advantages :

    • Group insurance
    • Hospitalisation insurance
    • Meal vouchers of 7 euros gross per working day
    • Reimbursement km or company car
    • Monthly allowance (80 euros net per month)
    • A 13th month
    • Training
    • Etc

    A rate as freelance is also possible.

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마감 시간: 22-01-2026

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