Sr Associate QA Complaints
SIRE
Noord-Brabant, The Netherlands
13 dagen geleden

The company

Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands. Our customer is one of the largest supplier of medicines in the Netherlands.

This is a unique opportunity to work in one of the largest pharmaceutical companies in the world!

Role description

Complaints handling (including performing assessments) in accordance with internal procedures, regulatory guidelines and business performance objectives.

Responsibilities

  • Initiate and own product quality complaints, Safety quality investigations and product security investigations for commercial and / or clinical products
  • Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection, Return sample inspection and Safety Features verification)
  • Partner with corporate product quality surveillance, assessors from other sites and contracted partners to resolve product complaint investigations
  • Partner with affiliates in country and intake call centers on call intake procedures and complaint investigations
  • Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
  • Assist in projects and improvement efforts as needed
  • Provide training to affiliate staff on complaint handling procedures and performing investigations / assessments
  • Initiate and own QA Non Conformances / CAPAs as needed
  • Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.
  • Requirements

  • MBO or Bachelor’s degree or equivalent
  • Typically 3 or more years of related professional experience
  • Fluent in English language
  • Experience in Quality Assurance, including handling product complaints investigations
  • Experience in pharmaceutical industry
  • Other information

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.

    Solliciteren
    Bij de favorieten invoegen
    Verwijder van favorieten
    Solliciteren
    Mijn E-mail
    Door op "Doorgaan" te klikken, geef ik neuvoo toestemming om mijn gegevens te verwerken en mij e-mailwaarschuwingen te sturen, zoals beschreven in neuvoo's Privacybeleid . Ik kan mijn toestemming intrekken of me op elk moment afmelden.
    voortzetten
    Aanvraagformulier