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NL CW Senior associate QA

For our client in Breda we are looking for a Senior Associate QA (GMP).

Job description

Complaints handling (including performing assessments) at the office in Breda 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 our client 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 our client 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 our clients Breda projects and improvement efforts as needed
  • Provide training to ABR and our client 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

Minimum Requirements

  • MBO or Bachelor’s degree or equivalent
  • Typically 3 or more years of related professional experience
  • Fluent in English language.
OR
  • Master’s degree or equivalent
  • Minimal related professional experience
  • Fluent in English language.

 

Preferred Requirements

  • Experience in Quality Assurance, including handling product complaints investigations
  • Experience in pharmaceutical industry
  • Benefits (optional)