Quality Support Engineer QA

Location Netherlands
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Merel van Os

Contact email: m.vanos@panda-int.com
Job ref: 19771
Published: 2 months ago

Quality Support Engineer QA – QS&E

For one of my leading Biopharmaceutical clients in Geel, Belgium I am looking for a Quality Support Engineer. You will be working on quality GMP compliance projects concerning Qualification of (process) equipment, utilities and facilities & automation systems.

RESPONSIBILITIES

  • Change Controls for equipment, utilities & facilities, automation systems.
  • Deviation/complaints Management  
  • Ensure quality oversight of the operational and project activities by documented QA approval of GMP documentation, periodic system quality reviews and by active participation in project teams including:
  • Review and approval of Qualification Documents (URS/SRS, Impact Assessments, PQP, DQ IQ OQ & PQ protocols & reports, QSR
  • Review and approval of cleaning test/monitoring/verification & validation protocols and reports, Change Controls
  • Review and approval of SAP Master Data, periodic monitoring and Periodic System Quality Review documents (PSQR)
  • Support in-depth investigations by providing technical, quality and compliance expertise
  • Define adequate CAPA’s for Quality Investigations regarding equipment, utilities and facilities, automation and cleaning with potential quality impact

PROFILE

  • Master’s Degree in scientific/technical discipline preferred
  • 2-4 years of working experience
  • Understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes
  • Knowledge of task related cGMP regulations and guidelines
  • Technical background and base knowledge of chemical/pharmaceutical process equipment
  • Strong analytical thinking, risk assessment and decision-making skills
  • Dutch and English (spoken as well as written)

PRACTICALITIES

Duration:           until 30-06-2023, high chance of extension
Start:                  ASAP (flexible)
Hours p/w:        Fulltime on-site in Geel

INTERESTED?

Get in touch ASAP by sending your CV to m.vanos@panda-int.com or call me on +31202044502! You can also refer a friend and both earn a bonus on placement.