Quality Specialist Benelux

il y a 4 semaines

Brainel'Alleud, Belgique Randstad Travail à distance Freelance Temps plein

We are looking for a Quality Specialist Benelux for one of our clients based in Braine-lâAlleud.

Don't hesitate to contact me : delphine.vanriet@professionals.randstad.be - Life Sciences Wallonie.

This is a contract as Consultant (employee or freelance): Project starting in June 2024 until 31/12/2024

key responsibilities

The goal of this function of Quality Specialist Benelux, is as follows:

  • To ensure global quality practices are integrated in the affiliate to ensure compliance is met with regard to our customer's  local regulations.
  • To maintain the GDP/GMP status of the affiliate in accordance with national and international GDP, GMP and legal requirements.
  • To ensure QA deliverables are achieved in a compliant timely manner.
  • To support the Benelux affiliate Quality in the ordinary and extraordinary tasks. 

    As Quality Specialist Benelux here are the tasks you'll do:

    • Product Complaint Management â Receipt of PQC from customers/ customer Cares,opening in eQMS, discussions with CCU and the complainant, organizing return sample shipments, replacement product to customer. Reporting outcome to the complainant.
    • Batch administrative GDP release - Full process of reviewing 3PL inbound documentation, transport temperature data, decide on GDP release to saleable stock.Release related communications with 3PL. Managing documentation approval and archiving in Source CD.
    • Administrative release of rework activities â Reviewing of 3PL batch documentation of local review, decide on GDP release to saleable stock. Rework related communications with 3PL. Managing documentation approval and archiving in Source CD.
    • Deviation Management, when Deviation originates in the processes covered by Quality Specialist, or when separately agreed. Typically opening and follow-up of primary transport deviations (shipment from global site to local 3PL) in eQMS, facilitating investigations by Global distribution Quality or other stakeholders.
    • Document and Record Management; Ensure archiving of documents in correct systems (TW, Source CD, Source Quality) for the processes Quality Specialist manages. 
    • Staff Qualification (ensuring Quality Specialist completes assigned trainings in a timely manner)
    • CAPA Management, as requested.
    • Change Control Management, supporting local change control processes as requested.
    • Vendor Management; Contact person to local 3PL, as agreed. Daily contact to 3PL for different distribution related questions including decision taking in case of temperature excursions.
    • Customer qualification; Checking Dutch customerâs documentation to verify eligibility to order, manage related approval and documentation in Source CD, as requested.
    • Internal and External Audit Management, supporting local audits and inspections andrelated CAPA work, as requested.
    • Recall Management, supporting local recalls and mock-recall, as requested.
    • Narcotics management, local administrative activities, as requested.

      qualifications

      As Quality Specialist Benelux, we expect the below competencies:

      • Master's Degree or Bachelor's degree
      • Has the ability to effectively interact with and influence internal personnel on product and quality related matters with a customer-oriented mindset.
      • Has a detailed, accurate way of working.
      • Has ability to manage complex administrative tasks and manage own work.
      • Has ability to analyze data and information to draw conclusions and make effective decisions and escalate as required.
      • Self-motivated team player, who can support new ideas.
      • Possess root cause and risk management/assessment skills as needed.
      • Fluent and confident use of local (Dutch and/or French) and English language verbally and in reading & writing.

        key benefits

        For this position of Quality Specialist Benelux, we offer an attractive salary with below benefits:

        • 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 a freelancer is also possible.

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