development compliance system specialist - 7903

☞ Randstad

View: 140

Update day: 16-11-2025

Location: Braine-l’Alleud Walloon Brabant

Category: IT - Software IT - Hardware / Networking Information Technology

Industry: HR personeel

Job type: Freelance

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Job content

Interested ? Don’t hesitate to contact me and take a look at the job description below !

megane.libert@professionals.randstad.be

Reason request: volume of business

    qualifications

    • development oriented mindset
    • experienced in pharmaceutical / biotechnology
    • experienced in data integrity concept and quality system
    • ability to write out sops
    • must be a team player
    • master / bachelor with relevant demonstrated experience
    • minimum 3-5 years experience
    • experience in a similar position in a similar environment
    • key technical backgrounds: general analytical techniques, knowledge in devices is a strong asset
    • mandatory skills: team player, compliant, rigorous
    • english: very good level (must lead meetings in english)
    • french: mandatory fluent

    key responsibilities

    job summary:


    device and delivery systems sciences (ddss) is accountable for the laboratory activities related to the development and industrialisation of new devices. the ddss takes care of the development and validation for the functional methods as well as the characterisation of the primary packaging and materials of contact for new chemical and biological entities (including gene therapy).

    ddss is looking for a compliance specialist in data integrity and quality management system to enable and strengthen the development quality system in the laboratory. the scope only covers non gmp activities. our client has started to implement good scientific practices (gsp = non gmp) in development units and the candidate will translate corporate sops into a local system (development). he / she will closely work with qa unit and lab people to roll out an adequate quality system following the gsp rules without impacting the laboratory agility. the candidate will also participate at various interdepartmental workshops to define the corporate gsp guidances. a relevant experience in analytical instrument implementation or qualification is an asset for the candidate.

    job description:


    operational

    • implementation of the remediation from the gsp gap assessment
    • enable the quality systems (sops, process,...) to remediate to the gaps (general quality management systems, equipment qualification, data management, etc)
    • participate and lead meetings to put in place the remediation plan and define the corporate guidances
    • write out the missing sops where needed
    • interaction with transversal entities (it, qa, stakeholders,...)
    the applicant needs to be autonomous and think pro-actively (senior level is preferred) but he / she will validate major decision points the the head of the laboratory and qa unit

    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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Deadline: 31-12-2025

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