Sr. QA Officer

Sr. QA Officer

Lonza

Geleen, Netherlands

The Sr Quality Assurance Officer interacts directly with internal customers on change, CAPA and Deviation management, documentation and projects. The role is to serve as the Lonza Subject Matter Expert and decision maker for change management throughout the facility. Capable of identifying and resolving quality issues with appropriate supporting documentation. This level Sr QA officer reviews and approves deviations, CAPAs and CRFs within their assigned area of focus. Sr QA Officers must be able to weigh the risk of the event and look for an efficient yet compliant solution. The Sr QA Officer provides superior customer service to internal customers. Mentor and train lower level and new specialists on basic quality tasks.

Key responsibilities:

  • Partner with internal customer as part of moderately complex change control, CAPA, Deviation review serving as the Quality Subject Matter Expert;
  • Supporting the site as final QA on all change control from the areas of MSAT, Engineering, QC, Validation and Manufacturing;
  • Attend meetings prepared to speak to the project/change and identify Quality requirements;
  • Consult with quality management on decisions to ensure alignment and agreement;
  • Completion of QA deliverables associated with change controls (tracking, lot assessments);
  • Review and approve Lonza SOPs, forms, and test methods within Document Management System. Responsibility is to ensure changes are justified; procedures are followed, and contain appropriate associated reference;
  • Review and approve deviations, CAPAs and CRFs within area of focus;
  • Review and approve non DMS documents;
  • Lead projects define project plan, scope, and deliverables as assigned. Manage and track Key Performance Indicator Quality metrics and attend other meetings- represent department at site meetings (when required);
  • Provide guidance to QA Officers;
  • Backup for Manager;
  • Suggesting training activities.

Key requirements:

  • Bachelor or Master degree in Science, Biotechnology or related discipline;
  • Extensive experience working in GMP environment;
  • Extensive experience in Quality Assurance or similar discipline;
  • Biotechnology manufacturing background is preferred;
  • Knowledge of GMP’s and regulations. Experienced professional who continues to improve and refine technical knowledge of quality systems;
  • Experience with Trackwise, SAP, Document Management system;
  • Self-starter, excellent written and verbal communicator at all levels, able to maintain composure, pays close attention to detail, works effectively individually and with all team members. Able to manage multiple activities within agreed timeframes with a challenging workload and changing priorities.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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