Michael Schrewe

Sales organisation of international concern, logistics and wholesale medicinal products and food supplements

• Development of a monitoring system for documentation Monitoring of drug distribution by external partners outside the EU in accordance with contracts and regulatory requirements
• Preparation and migration of regulatory and quality documents into VEEVA system, archiving
• Review and preparation of QA documents in accordance with GMP and GDP guidelines
• Working with VEEVA, SharePoint, ComplianceWire
• Research of regulatory requirements for imports to Canada and the USA Achievements: Created a monitoring tool and documentation data base, prevented non allowed imports to EU, successful migration of thousands of critical regulatory and quality documents.

• Deviation management and CAPA management for production of final pharmaceuticals, process, close and reduce open CAPA events
• Deviations: document, enter into system, handle/evaluate events, risk analysis, root cause analysis
• Define, verify and close CAPA actions, prepare for release of pharmaceuticals by the Qualified Person
• Organize and moderate meetings to clarify and close CAPAs
• Reduce backlog of open deviations/CAPAs in preparation for FDA inspection
• Achievements: Processed backlog of unaddressed/unassessed deviations and CAPAs, handled deviations promptly and accelerated, 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
• Reviewing and auditing quality documentation, batch records, validations, qualifications, computerized systems, data integrity (audit trail), analytical methods at CROs and CMOs
• Organizing change management, CAPA management, and deviations at CROs and CMOs; supporting risk analyses and root cause analyses
• Responsible for quality compliance and quality management system at CROs and CMOs
• Drafting Quality Assurance Agreements (QAAs) together with CROs, CMOs, contractors, and suppliers; creating supply chain maps
• Supplier qualifications and external audits (GMP, GLP, GCP, GDP)
• Organizing, conducting, and supporting quality audits at CROs and CMOs to qualify external partners
• Achievements: brought quality and documentation issues with suppliers and CMOs under control; significantly reduced the backlog of missing audits and QA agreements; obtained missing regulatory documents for submission

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

• Revising, further 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 developing new ones for new products
• Creating and updating SOPs, forms, change requests; developing user-friendly documentation tools for employees in the high-potency area
• Working with DMS (SAP); developing documents that integrate with the secure DMS
• Achievements: developed a modular system for master batch records, enabling quick creation and adjustments; created SOP documents, forms, and other necessary documents

• Preparing for FDA inspection (inspection readiness), organizing mock audits (compliance checks, data integrity, GMP, hygiene)
• Organizing and conducting employee training on GMP and hygiene
• Advising and optimizing hygiene concepts in the GMP production area
• Creating training materials and documenting the 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, passed the FDA inspection successfully

• Managing 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 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, successfully passed customer audits with few findings

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

• Support and further development of the quality assurance program (OECD, ICH Q9, Q10)
• Creation, updating and monitoring of quality management guidelines
• Audits for GLP studies, internal labs and external CROs, support in GCP(V) study audits (compliance, data integrity)
• Organization of study director meetings and employee training
• Support of GLP inspections by authorities
• Importing audit observations into databases, evaluation for management
• Preparation of site quality review reports
• Organization and optimization of the SOP system
• Initiation and consulting in 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
• Establishment 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 system
• Process development for encapsulation of human cells for an oncology cell therapy project
• Preparation and execution of GMP productions