• Manage allocated projects ensuring adherence to schedule, budget and compliance with EHS and GMP requirements.• Provide technical support and expert advice as required to support manufacturing and project objectives • Facilitation of project execution through motivating team members, encouraging participation and good team working conditions. Ensure clearly defined Roles for project team, values feedback • Communicating and influencing key stakeholders in support of the project. • Provide cost and time estimates for defined project tasks to allow capital budgets and Capital Expenditure Requests to be proposed for approval. • Assess project tasks for potential impact on company procedures (Safety, Health, Environmental and cGMP) and to identify (with relevant support) suitable actions to minimise risk.• Organise with Manufacturing and Maintenance teams activities for equipment commissioning, qualification and handover.• Line Management responsibilities

Main Responsibilities• Act as the operational serialisation Subject Matter Expert, covering the serialisation equipment and processes within the packaging operation.• Work closely with the internal Quality, Engineering and Project Management departments as well as the global serialisation team to ensure the long term serialisation strategy for the business is successfully implemented.• To ensure that customers are on-boarded successfully and efficiently with ‘minimal to zero’ impact to order delivery dates. • To create a project team and provide appropriate leadership to support.• Be technically proficient in regards to the Serialisation process, equipment and product, to fulfil the role of the Serialisation Subject Matter Expert. • In conjunction with global Serialisation team, design, implement and maintain the control strategy for the Serialisation processes.• Provide training to the operational teams on applicable software and hardware as required. Ensure all relevant production staff are fully familiar and/or trained with the equipment, process & documentation

- Identify and facilitate process improvement projects, training/ workshops to drive cultural change - Conduct root cause analysis to determine metrics, troubleshoot manufacturing/ business and manufacturing issues, material flow, project plans, production capacity, facility design and create process documentation - Carrying out data collection and analysis for process mapping, develop budgets and cost analysis to determine project feasibility- Drive value stream mapping to define “As-Is Analysis” and the transition to Future State - Develop and conduct compliance audits, program evaluations and reviews to drive results with the fortitude to ensure sustainability - Project managed the implementation of serialisation equipment and processes.- Currently project managing the onboarding of several major customers in preparation for serialisation.

• Responsible for Safety and Security of the aircraft, passengers and Cargo on board• Assist the commander as requested, concerning any administrative duties in relation to the flight• Safe navigation of the aircraft, maintaining a continuous and independent check upon both the geographical position of the aircraft and systems• Conducting the flight in compliance with the current flight plan, SOPs• Maintaining a high personal standard of discipline, conduct and appearance• In the event of Commander Incapacitation adopt command

Responsibilities include• Lead the construction, maintenance and continuous development of the Quality Management System to supporting the ongoing business and regulatory requirements • Build a team of SMEs to ensure that and effective QMS is maintained on the site • Maintain site Audit readiness state • Prepare and co-host regulatory inspections (FDA, TMoH, ANVISA) and host customer audits • Maintenance of the Site Master File • Quality Lead Auditor (GMDP, ISO 9001)• Oversee and participate in Internal and External Auditing programme.• Ensure that all QMS elements regarding Investigations, CAPA, complaint, trending and recall systems are maintained in a compliant state and communicated effectively to appropriate personnel• Ensure that Quality metrics are accurate and effectively managed for the site • Maintenance and upkeep of the Vendor Management programme

Planning, developing, and implementing ISO and cGMP compliance elements to enhance the Quality Management System.Responsible for project management to execute implementation plans, and drive quality objectives, goals and measurement systems

Reporting to the Senior Manager. Providing support in the management of clinical and commercial drug product packaging (NPI) and contract manufacturers. Provide support in the management of internal Quality Systems.

Execute and maintain of the Quality Management System for EMEA Quality Compliance to meet current regulatory requirements, including but not limited to the Deviation, Customer Complaints, Internal Audit, Quality Risk Management, Product Quality Review, Change Control, Training, and Documentation.