Michael Schrewe

Sales organization of an international group, handling logistics and wholesale of medicinal products and food supplements.

• Developed a monitoring system to track drug distribution by external partners outside the EU in line with contracts and regulatory requirements
• Prepared and migrated regulatory and quality documents into the VEEVA system, archiving them
• Reviewed and prepared QA documents according to GMP and GDP guidelines
• Worked with VEEVA, SharePoint, ComplianceWire
• Researched regulatory requirements for imports to Canada and the USA Achievements: Created a monitoring tool and documentation database, prevented unauthorized imports to the EU, and successfully migrated thousands of critical regulatory and quality documents.

• Deviation and CAPA management for final drug manufacturing: handling, closing and reducing open CAPA events
• Manage deviations: document, enter into system, handle and evaluate events, perform risk analysis and root cause analysis
• Define, verify and close CAPA measures, and prepare products for release by the Qualified Person
• Organize and facilitate meetings to clarify and close CAPAs
• Reduce the backlog of open deviations and CAPAs in preparation for FDA inspection
• Achievements: Processed the backlog of unassessed deviations and CAPAs, addressed deviations promptly, and defined CAPAs

• Handling liquid forms, sterile filling and production, IMP (investigational medicinal products), upstream processing (USP) and downstream processing (DSP)
• Quality assurance for biotech/biosimilar projects in collaboration with CROs, CMOs, suppliers and contractors
• Review and audit of quality documentation, batch records, validations, qualifications, computerized systems, data integrity (audit trail), analytical methods at CROs and CMOs
• Organization of change management, CAPA management and deviations at CROs and CMOs, support with risk assessments and root cause analyses
• Responsible for quality compliance and quality management system at CROs and CMOs
• Creation of quality assurance agreements (QAAs) together with CROs, CMOs, contractors and suppliers, supply chain maps
• Supplier qualifications and external audits (GMP, GLP, GCP, GDP)
• Organization, execution and support of quality audits at CROs and CMOs to qualify external partners
• Achievements: brought quality and documentation issues at suppliers and CMOs under control, significantly reduced the backlog of missing audits and QAAs, obtained missing regulatory documents for submission

• Conducting trainings (in-house, external, webinars)
• Creating training materials (topics: GMP, GLP)

• Revising, developing and harmonizing master batch records, developing a system for creating master batch records
• Creating, optimizing and harmonizing manufacturing instructions for GMP production of existing drugs and creating them for new products
• Creating and updating SOPs, forms, change requests, developing user-friendly documentation options for employees in the high potency area
• Working with DMS (SAP), developing documents that work with the sensitive DMS
• Achievements: developed a modular system for master batch records, enabling quick creation and adjustment; SOP documents, forms and other documents were created

• Preparing for FDA inspections (inspection readiness), organizing mock audits (compliance checks, data integrity, GMP, hygiene)
• Organizing and conducting employee training on GMP and hygiene
• Advising on and optimizing hygiene concepts in the GMP production area
• Developing training materials and documenting training sessions
• Conducting internal audits in production, identifying and reporting potential issues according to ICH Q9/Q10
• Achievements: Trained large parts of the workforce before the FDA inspection, conducted a mock audit, identified and resolved weaknesses, successfully passed the FDA inspection

• Supporting and further developing the quality assurance program (ICH Q10, IPEC)
• Releasing batches (SAP), reviewing batch records, preparing certificates of analysis (CoAs)
• CAPA management, deviation management, root cause analysis
• Complaint handling, change management, risk management according to ICH Q9
• Organizing and supporting supplier audits by customers
• Advising on and optimizing hygiene concepts during renovation and expansion of production facilities
• Preparing PQRs and quality assurance KPIs
• Reviewing and approving SOPs (MasterControl)
• Achievements: Reviewed and released a large backlog of batch records, optimized the CAPA system, closed numerous CAPAs, successful customer audits with few findings

• Development and revision of SOPs for the Quality Management department
• Managing CAPA plans
• Achievements: Successfully revised SOPs and translated them into the local language, closed CAPAs

• Support and development of the quality assurance program (OECD, ICH Q9, Q10)
• Creation, updating, and monitoring of quality management policies
• Audits for GLP studies, internal labs and external CROs, involvement in GCP(V) study audits (compliance, data integrity)
• Organization of lead auditor meetings and staff training
• Support of GLP inspections by authorities
• Entering audit observations into databases, analysis for management
• Preparation of Site Quality Review Reports
• Organization and optimization of the SOP system
• Initiation and consulting for validation and qualification

• Implementation of the GLP standard for GLP certification in the Preclinical Development department
• Development and validation of assays and methods (immunological, virological), equipment qualification
• Setup and organization of the Encapsulation Research Group: polymer development and optimization, process development and optimization of polymer production, technical development and optimization of encapsulation processes
• Work in the CapCell division: technical development, optimization of production processes, validation and qualification of the encapsulation equipment
• Process development for encapsulation of human cells for an oncology cell therapy project
• Preparation and execution of GMP productions