Overview

Reference Number: JO-2106-470060
QA/QC Officer
Rate: Negotiable
Job Type: Permanent
Location: Frankfurt am Main

Our client are a global pharmaceutical services company specialising within Clinical trials based in Frankfurt.

They have a great opportunity for a Quality professional to join their business and work along side the European Quality Head/QP.

Key Responsibilities:

  • 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.
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