Sr Associate QA

Location Netherlands
Discipline: Biotechnology
Contact name: Beata Wydurska

Contact email: b.wydurska@panda-int.com
Job ref: 19840
Published: about 2 months ago
I am looking for Sr QA Associate to join well-known biopharma company in Breda.
Objective of the role is Complaints handling (including performing assessments) in accordance with internal procedures, regulatory guidelines and business performance objectives.

Responsabilities: 
  • 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 ABR 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.
Qualifications:
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.

Minimum qualifications:
  • MBO or Bachelor’s degree or equivalent
  • Typically 3 or more years of related professional experience
  • Fluent in English language
  • 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
Practicalities: 
  • Location: Breda 
  • Working 1-2 days/week on site is expected
  • Long-term contract 
  • Full time 
If interested, apply here! Or send your CV to b.wydurska@panda-int.com or call +31 20 20 44 502.