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

The company

Our client is a professional organisation, based in Noord-Brabant Netherlands. This is one of the biggest pharmaceutical company in the world.

Role description

Complaints handling (including performing assessments) at our site 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 Breda 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 Master’s degree
  • 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.

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