Gabriela Constantin Email & Phone Number

Bucharest, Romania

Organizes and conducts regular GMP/GDP audits in order to ensure compliance with the current regulatory requirements.Preparation for and participation in regulatory inspections (NAMMDR, EMA, FDA, Russian Authority, etc.), internal audits, customer and supplier audits.Ensures proper and timely implementation of the established actions after audits and regulatory inspections.Monitors the internal and external audit plan as well as provides support in updating the status according to… Show more Organizes and conducts regular GMP/GDP audits in order to ensure compliance with the current regulatory requirements.Preparation for and participation in regulatory inspections (NAMMDR, EMA, FDA, Russian Authority, etc.), internal audits, customer and supplier audits.Ensures proper and timely implementation of the established actions after audits and regulatory inspections.Monitors the internal and external audit plan as well as provides support in updating the status according to the plan.Collaborate with National Agency for Medicines and Medical Devices of Romania for the development, submission and receipt of the documents as well the reports for exports, imports and monthly reporting.Participates and provides support in the transfer of new products and or the implementation of new and alternative manufacturers.Performs the annual approved suppliers evaluation process.Investigates deviations, collecting records to determine the root cause, establishing corrective and preventive actions and monitoring their implementation.Review and update of Quality Agreements with third parties according to current regulatory requirements.Perform specific risk analyzes when a potential or actual risk is identified.Elaborate/Update of Site Master File of the manufacturing site.Investigates or participate in the investigation of OOS/OOT results occurring in the routine manufacturing or as part of the stability testing program.Manage the quality module in SAP S/4HANA.Maintain the Quality Management System.Handling of changes that have an impact on processes, systems and premises.Review the compliance, verify and approve relevant documentation for cGMP (SOPs, BMRs, etc.).Participate in staff training on materials management topics. Show less

Production

Coordinate the production activity for monitoring the projects in the established parameters and their implementation in order to achieve the planned objectives.Provide support for the transfer of new products to the packaging equipment.Elaborate the packaging documentation for new products.Participate in the activity of investigating complaints and deviations following the rules of the Good Manufacturing Practice (GMP) and the Standard Operating Procedures (SOP) in… Show more Coordinate the production activity for monitoring the projects in the established parameters and their implementation in order to achieve the planned objectives.Provide support for the transfer of new products to the packaging equipment.Elaborate the packaging documentation for new products.Participate in the activity of investigating complaints and deviations following the rules of the Good Manufacturing Practice (GMP) and the Standard Operating Procedures (SOP) in force.Propose corrective and preventive actions for non-conformities detected on the flow.Gets involved in the control system of the changes that take place within the department.Establish the routing on the packaging phase for all products.Participate in tests and reports for packaging materials (MA) from alternative manufacturers.Organize and conduct regular training on GMP and relevant SOP for packaging staff. Show less

Quality Control

Identify and apply appropriate solutions to improve performance by addressing the issues of organizational process.Analyze of the root causes of the identified problems, using appropriate methods, such as: SWOT, Pareto diagram, brainstorming, question method, cause-effect diagram.Evaluate the consequences of the implemented improvement actions.Implement reduced testing for active substances, excipients and IPC.

Master'S Degree, Biochemistry And Molecular Biology

Bachelor'S Degree, Biochemistry