Manufacturing, Science and Technology SME (specialising in Packaging) for a number of CMOs within the EMEA region. - liaison for CMO technical issues and non-conformities during packaging/manufacturing of BMS products - BMS project manager for changes / improvement / tech transfer initiatives at CMOs - analysis of packaging robustness data - BMS coordinator for introduction of serialisation at CMOs

• Site Operations Lead for the introduction of serialization / aggregation capability to ensure compliance with regulations requiring enhanced security and traceability in pharmaceutical supply chains globally• Process owner for the packaging operations and associated tasks for the ‘Specialty Packaging’ IPT.• Stand-in / delegate for IPT Lead• Initiate and formulate proposals for improvement projects• Effectively lead team of cross / inter functional representatives to ensure realization of compliance, efficiency and effectiveness improvements.• Experienced LSS YB and GB (and associated tools) practioner• Investigate problems / issues using LSS methodology (MPS tools) to identify the root cause and implement effective actions to ensure non recurrence.• Lead and participate in ‘Kaizen’ events. Identify improvements, identify and manage the implementation of appropriate actions and ensure changes are sustained.• Monitor and optimise compliance, processes and systems in the IPT to ensure that they are executed in line with guidelines and procedures.• Initiate and execute quality improvements within the IPT.• Investigate issues / problems (e.g. complaints, PQRs, trend analysis etc.) and implement appropriate solutions (to avoid recurrence).• Acting as a liaison and project manager between CMO / suppliers and internal site personnel to resolve manufacturing, quality and technical issues and to facilitate proactive quality improvements of the CMO / supplier’s manufacturing processes.• Drive yield improvements• Owner of QMS sub-system for all activities related to printed and non-printed packaging components.• Ensure IPT quality documents are in line with quality guidelines and procedures.• Own all operations related data held within ERP.

• Manage a team of 10 Quality Inspectors to ensure that all packaging components are sampled, tested and dispositioned within agreed lead-times• Manage sampling of all pharmaceutical raw materials (APIs and excipients)• Manage the vendor complaint system, including ensuring that all manufacturing, quality and technical issues are investigated to determine exact root cause and appropriate actions are identified and tracked to closure to avoid recurrence.• Monitoring supplier’s quality performance.• Implement and manage the vendor certification system (for all packaging components)• Manage the system for non-conforming material• Lead auditor for vendor audit program• Identify and implement appropriate CAPAs based on internal and external audit findings.

• Coordinate Customer Complaints System (including supervision of a dedicated team)• Coordinate Internal Audit System• Coordinate External Audits (preparation and responses)

Chemical analysis of raw materials, intermediate and finished products.