Experience

Cellex Cell Professionals

• Germany
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Officer

  • Sep 2019 - Present

  Collaborate with manufacturing and quality control functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality. • Support the authoring of Batch Records, providing quality input. • Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality. • Review and evaluate executed manufacturing batch… Show more Collaborate with manufacturing and quality control functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality. • Support the authoring of Batch Records, providing quality input. • Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality. • Review and evaluate executed manufacturing batch records to facilitate disposition of intermediate product Batch release. • Review of protocols, reports and SOP’s as a function of QA. • Review and participate in deviations and changes to manufacturing / QC operations to ensure appropriate investigation and assessment is carried out and actions implemented and monitored. • Ensure continued product quality through the Quality System by: - Participate in self inspections and internal audits. - Use of Quality Risk Management and improvement activities. • Support and Management of the QA-team as team-lead since beginning 2021 Show less Collaborate with manufacturing and quality control functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality. • Support the authoring of Batch Records, providing quality input. • Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality. • Review and evaluate executed manufacturing batch… Show more Collaborate with manufacturing and quality control functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality. • Support the authoring of Batch Records, providing quality input. • Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality. • Review and evaluate executed manufacturing batch records to facilitate disposition of intermediate product Batch release. • Review of protocols, reports and SOP’s as a function of QA. • Review and participate in deviations and changes to manufacturing / QC operations to ensure appropriate investigation and assessment is carried out and actions implemented and monitored. • Ensure continued product quality through the Quality System by: - Participate in self inspections and internal audits. - Use of Quality Risk Management and improvement activities. • Support and Management of the QA-team as team-lead since beginning 2021 Show less



ATV GmbH

• Germany
• Professional Training and Coaching
• 1 - 100 Employee

• Teilnehmer postuniversitäre Weiterbildung "Life Science Management"

  • Mar 2019 - Aug 2019

  pharmaceutical management: - Current legal and health policy basics - Planning and implementation of clinical studies (monitoring, GCP) - Drug approval (regulatory affairs), drug safety - Quality management, quality assurance - Sales structure and organization, distribution of pharmaceutical and medical products - Pharma Business Economic foundations: - Project Management (MS Project) - Business management basics (company organization, internal processes… Show more pharmaceutical management: - Current legal and health policy basics - Planning and implementation of clinical studies (monitoring, GCP) - Drug approval (regulatory affairs), drug safety - Quality management, quality assurance - Sales structure and organization, distribution of pharmaceutical and medical products - Pharma Business Economic foundations: - Project Management (MS Project) - Business management basics (company organization, internal processes, accounting, controlling) - Marketing personality training: - Self and time management - Rhetoric and presentation - Team and leadership training - Personal marketing strategies Show less pharmaceutical management: - Current legal and health policy basics - Planning and implementation of clinical studies (monitoring, GCP) - Drug approval (regulatory affairs), drug safety - Quality management, quality assurance - Sales structure and organization, distribution of pharmaceutical and medical products - Pharma Business Economic foundations: - Project Management (MS Project) - Business management basics (company organization, internal processes… Show more pharmaceutical management: - Current legal and health policy basics - Planning and implementation of clinical studies (monitoring, GCP) - Drug approval (regulatory affairs), drug safety - Quality management, quality assurance - Sales structure and organization, distribution of pharmaceutical and medical products - Pharma Business Economic foundations: - Project Management (MS Project) - Business management basics (company organization, internal processes, accounting, controlling) - Marketing personality training: - Self and time management - Rhetoric and presentation - Team and leadership training - Personal marketing strategies Show less