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Company was changed due to separation Haleon from GSK.ResponsibilitiesEnsure LOC Quality processes and systems are in place for all activities carried out across the Local Business ensuring as well that they are in compliance with standards and policies, GMP, GDP and regulatory requirements.Accountable for review and approval:TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.Batch… Show more Company was changed due to separation Haleon from GSK.ResponsibilitiesEnsure LOC Quality processes and systems are in place for all activities carried out across the Local Business ensuring as well that they are in compliance with standards and policies, GMP, GDP and regulatory requirements.Accountable for review and approval:TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.Batch management & Release to Market: to lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards.Third party management: Quality assessment and Quality Agreements with Third Party Supplier (3PL) providing GxP services to the LOC, support of new routes establishment Recall and incident management. Support of new products introduction from quality perspectiveProvide quality input in the cross- function projects such as Serialization, new regulations on product release etc. Show less

Ensure LOC Quality processes and systems are in place for all activities carried out across the Local Business ensuring as well that they are in compliance with standards and policies, GMP, GDP and regulatory requirements.Accountable for review and approval:Quality Agreements with Third Party Supplier (3PL) providing GxP services to the LOC;TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical… Show more Ensure LOC Quality processes and systems are in place for all activities carried out across the Local Business ensuring as well that they are in compliance with standards and policies, GMP, GDP and regulatory requirements.Accountable for review and approval:Quality Agreements with Third Party Supplier (3PL) providing GxP services to the LOC;TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.Batch management & Release to Market:To lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards.Local Repacking. Manage all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures.Recall and incident management. Support of new products introduction from quality perspectiveProvide quality input in the cross- function projects such as Serialization, new regulations on product release etc. Show less

Operation and development of Quality Management System in the pharmaceutical sales organization: GxP-processes/ documentation/ training/ audits.Responsibilities:Developing/implementation of SOP for the GxP-processes according to international standards and authority requirements.Support of local departments (GxP and non-GxP functions) on SOPs creation; verifying compliance of SOPs draft to local QMSPreparing and conducting trainingsDeviation managementPerforming… Show more Operation and development of Quality Management System in the pharmaceutical sales organization: GxP-processes/ documentation/ training/ audits.Responsibilities:Developing/implementation of SOP for the GxP-processes according to international standards and authority requirements.Support of local departments (GxP and non-GxP functions) on SOPs creation; verifying compliance of SOPs draft to local QMSPreparing and conducting trainingsDeviation managementPerforming qualification audits of vendors (Preparing of Quality Assurance Agreements)Complaints and recall handling Show less

Implementation and development of QMS in the laboratory performing pre-clinical studies.

Development and conducting of bioanalytical assays for ADME-properties determination of prospective drugs.