You will be working in the European Headquarters of an American international Biopharmaceutical company. They are focusing on fighting serious, life threatening illnesses which have little to no cure. Would you like to join them on their noble mission to serve patients?
As a QA specialist clinical manufacturing/clinical supply chain, you will be mainly responsible for providing QA oversight on the supply chain of clinical trial products, QA guidance and support in the production area and clinical product disposition. You are responsible to provide quality guidance and direction to clinical operations, production, warehouse/distribution staff and global clinical supply chain management (GCSCM) assuring that cGMP standards are maintained.
- Identify issues and work cross functionally to ensure a solution.
- Collaborate cross-functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
- Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to SOP`s, Deviations, CAPAs, Change Control records and validation records. May also support execution of these tasks
- Act as a QA contact for deviations and complaints by participating in investigations, root cause analysis and CAPA`s
- Perform impact assessment as part of change controls impacting production or clinical QA processes
- Assist in risk assessments and validation activities as needed including review and approval of applicable documents.
- Support Continual Improvement initiatives, programs and projects as a SME
- Represent the quality unit during audits and inspections as needed
- Provide QA oversight on LSP`s.
- Assist in the development of GMP and Quality Systems training activities and provides training
- Alert senior management of quality, compliance, supply and safety risks.
- Develop and maintain effective partnering relationships with customers and stakeholders.
- Master’s in science in Pharmacy or equivalent
- Previous experience in a GMP environment
- Understanding of pharmaceutical development and clinical trial processes is preferred
- Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49.
Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.