Support the Sr Quality Engineer for ensuring quality and compliance aspects and ensure completion of optimization projects in fielding of quality and compliance issues and improvements for the assigned result areas. Support the Sr Quality Engineer for international audits.
Execution of the quality/manufacturing policy to ensure all necessary conditions to support the business process within Abbott Biologicals Olst are realized.
Tasks and Responsibilities:
Ensure availability of up-to-date documents, necessary to comply with the GMP guidelines.
Review proposals to amend documents.
Research and report on causes of minor and medium defects/disturbances.
Timely completion of department audits, as indicated in the department handbook, through design and management of a monitoring system for the performance and reporting of audits. Also carry out departmental audits and guide /comply with external audits and inspections.
Support production teams:
Prevent and reduce the number of complaints and non-conformities through initiatives and advice regarding improvement, coordinate response(s) from the department.
Ensure timely adjustment of documents or the production of new documents concerning changes' in processes and practices.
Preparation of documents.
Liaising with Quality systems regarding the management of documents and the authorization procedure.
Review of produced batches.
Provide document training as part of the job classification system.
Contribute to small projects.
Well-functioning task and job qualification system for the department staff, involving management and timely adjustment of the task and job qualifications (or ensuring they are adapted) and handling of the associated reporting as described in the department handbook.
Quality assurance: Performance of the work in Accordance with the requirements of the applicable quality assurance systems (GMP, ISO) and legislation.
Participate in and develop deviation studies.
Ensure implementation of improvements in production (within the department).
Education and experience:
Higher thinking and working level (technical or medical) Environment.
1 to 3 years’ experience in a relevant work environment.