They have a great opportunity for a Quality professional to join their bussiness and work along side the European Quality Head/QP.
- Support of and review of Master Packaging Records as well as warehousing and room logs.
- Provision of support for ongoing packaging projects in the Clinical Supplies Unit in form of in-process Quality Control and Quality Control of final product.
- Ensures reporting of violations of GMP regulations via the appropriate channels and procedures and contribute to re-training of Clinical Supplies Team.
- Support of and release of Logbooks for storage rooms, packaging rooms, cooling chambers, printers, etc;
- Perform, issue control and follow-up on quality events, such us complaint handling and the deviation management process to perform proper investigations, root cause analysis and CAPA definition where applicable
- Support and perform change control management.
- Review and Approval of client/vendor deviations, perform investigations and work in close cooperation with the Project Management .
- Support annual self-inspection in close cooperation with the QP of the GMP facility as required by German AMG and reporting to Executive Management.
- Support maintenance of the Site Master File .
- Support of validation activities for the GMP facility, e.g. for the cooling chambers.
- Revision, maintenance and accessibility of procedural documents in the GMP facility.
- Preparation, hosting and follow-up of client audits and Regulatory Inspections in the GMP facility.
- Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
- Ensure timely completion and documentation of all training requirements.
- Stay current on updates to regulations, guidelines and principles related to Good Manufacturing Practice (GMP) and advise on their use and compliance.
- Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations.
- Other duties, as required by the Quality Assurance department
- Support the performance of GMP Vendor Qualification Audits, in collaboration with the QP and the EU Director Quality.