Ewa Danielczak-Kozłowska

• Responsible for review and approval of laboratory documentation
• Creation and issuing of relevant laboratory documents
• Coordination and maintenance of Controlled Documentation System
• Creation and review of Method Validation Protocols and Reports
• Health and safety activities including safety audits
• Experience in Process, Method Validation, Method Transfer and Stability
• Process Validation activity for solid dose forms (tablets, capsules)
• Review of API testing for Supplier Qualification Project
• Technical Knowledge in analytical techniques: HPLC, UV, GC , Dissolution,
• Technical Knowledge in analytical testing: powder, and tablets, capsules physicals testing, blend and content uniformity,, dissolution, related substances
• Laboratory CAPA database maintenance, writing CAPA annual reports
• Laboratory Investigation Report issuing, maintenance
• Writing, updating and maintenance of SOP’s, TD Analytical protocols and report
• Product Specification maintenance
• Support Technical Development Department in method updates and change control
• Creation and review of Certificate of Analysis for API and FP
• Provide technical support and mentoring to Analyst in quality, laboratory documentation, health & safety area
• Archiving
• Training files updating and maintenance
• Responsible for carrying out the internal quality system audit, writting quality audit reports

• Responsible for review and approve of laboratory paperwork, equipment logbooks and logfiles
• Creation and issuing of relevant laboratory documents, logbooks maintenance and archiving
• CAPA database maintenance
• Laboratory Investigation Report issuing, maintenance
• Laboratory equipment calibration and maintenance
• Health and safety activity, meetings and safety audits

• Responsible for creation of the raw materials and products specification
• Preparation of the analytical test method according to the European Pharmacopoeia, GMP regulation
• Maintenance and archiving of quality system records and product specification according to GMP regulation

• Responsible for implementation, coordination and maintenance of the ISO quality system in the company
• Creation and maintenance of quality documents and records
• Responsible for carrying out the internal quality system audit
• Provide the quality system training for staff
• Staff personal files maintenance
• Administration duties and activity

• Responsible for daily raw material, in process and finished product chemical testing
Techniques included HPLC, UV, titration analysis, density, viscosity, consistency, pH measurements
• Supplier qualification
• Creation and maintenance of quality system records
• Quality auditing according to ISO, HACCP. GLP