Goal: to ensure compliance and execution of the implementation of Projects within the company's Supply Chain.
- Assure that compliant, aligned, lean and efficient quality processes, systems and tools are designed, deployed, implemented, monitored and maintained in order to support the intended supply flows and logistical activities, from the initial phase of commissioning the site through to commercial activities and that compliance with cGMP and cGDP is ensured & maintained through ongoing training and process review and on-going monitoring of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) as applicable.
- Develop Quality-related procedures and Quality workflows for all Warehousing and Distribution activities to ensure Market Actions, Stop Distributions, Quarantine shipments, Returns, Damaged good handling, Destructions, Complaint Handling, Re-labeling & Repacking, Cold Chain storage and distribution are conducted in compliance with procedures at the LSP,
- Ensure GMP & GDP critical documentation generated during assigned projects is properly prepared, managed and archived,
- Develop and implement SOPs and job aids at the Logistic Service Provider meeting the requirements of the Quality Standards and in compliance with market regulations comply
- Quality Systems: Support in the Design and deployment of compliant, robust, aligned, lean and efficient quality systems and tools at the LSP to support GMS and commercial strategy, and to support the product lifecycle and supply flow,
- Ensure compliance of site validation activities to ensure compliance with industry regulations for validation activities which include but are not limited to manufacturing and lab equipment, utilities and facilities qualification, computerized system validation and QA IT tools implementation, process transfer and validation, analytical method validation.
- Risk management: Designing and implementing a quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle and supply flow
- Operational excellence: Drive continuous improvement initiatives which positively impact the site Quality level and assure the use of operational excellences tools in quality procedures and processes,