QA Officer / Omgeving Utrecht

De opdrachtgever

Farmaceutisch bedrijf omgeving Utrecht.

De omschrijving

  • SOP training, Annual GMP/GDP refresher Training to the personnel involved in GMDP activities.
  • Qualifying customers and suppliers, to perform periodic checks and archive their documentation.
  • Taking part in external audits along with the Lead auditor.
  • Arranging/taking part in self inspections.
  • Drafting justification for product variations.
  • Logging in complaint database, notifying QA team plus management. Reviewing market complaints and to submit to QA Manager for its final closure.
  • Preparation of new SOPs ,updation of new Sops and its final archival – including SOP for contract warehouse.
  • Preparation and updating of Release Forms and Receipt Sampling Release Distribution Forms.
  • Coordinating master document review of contract manufacturers and archival.
  • Coordinating Validation Protocol and Validation Report review of contract manufacturers and archival.
  • Instructing the warehouse to sample and to send batch samples to approved QC labs for testing and QP sample to release site.
  • Instructing the warehouse when they report deviation.
  • Instructing QC labs.
  • Instruction of Dutch CMO (packaging / sampling bulk tabs).
  • Contacting supply chain department on day to day issues and prioritized batches.
  • Compiling and check relevant documents required for batch release and to coordinate with QPs when batches docs are ready for review and release.
  • Notifying the team if any deviation is observed during the review of temp data, test data, artworks, batch documents.
  • Releasing the batches on Oracle after receipt of release certificates from QPs of other release site.
  • Generating monthly report of new complaints/deviations for management + PV responsible person.
  • Representing QA in monthly quality meetings with management.
  • Providing slides for monthly quality meetings.
  • Assisting on incoming compliance checks.
  • Coordinating CMO PQR reports and assisting compilation of PQR report.
  • Coordinating Medicine Waste: QP samples + expired samples and damaged packs at warehouse.

De eisen

HBO completed education.
Several years experience with QA within Pharmaceutical Industry.

De arbeidsvoorwaarden


Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Maliebaan 80
3581 CW Utrecht
tel 030 231 7350
mobiel 06 50650550