mark savage

* Provision of quality guidance to production team through daily / weekly meetings and presence on the manufacturing floor * Monitoring of GMP compliance, GMP programs and systems. * Training, mentoring and advising technical support and production personnel in GMP, change management, deviation investigation and process / equipment / utilities validation * Review and approval of deviations, including the assessment of impact on quality, validation, stability etc. and the assessment of investigation effectiveness wrt root causes analysis and proposed countermeasures/improvements * Review and approval of changes, including impact and risk assessment * Review and approval of process documentation including master batch records, recipes, specifications and procedures * Review and approval of GMP documents associated with process, uniformity, degradation and cleaning validation * Audit of systems and areas for compliance with policies, guidelines and procedures * Preparation of area for inspection activities and supporting execution of inspections

* Scheduling of QC Analyst activities to ensure that the team operates as efficiently as possible. * Leading laboratory investigations, ensuring compliant and timely documentation and resolution of events. * Reviewing and updating testing standards and test methods * Oversight of the maintenance, calibration and troubleshooting of laboratory equipment * Managing schedules to ensure testing, training and development needs are balanced * Preparing, maintaining and improving laboratory SOPs * Maintaining laboratory records and analytical data to an acceptable GLP/GMP standard * Liaising with other departments in relation to QC testing and release * Liaising with external suppliers/vendors in relation to QC consumables and equipment * Development of Analysts, by involving them in all aspects of the running and improving of the QC activities and providing them with opportunities to work with cross-functional stakeholders and customers

* Key responsibilities: * Finished Goods and Raw Materials analysis * Stability testing and development of related systems (Feb’00-Oct’01) * Calibration and troubleshooting of laboratory equipment * Maintenance of laboratory records and data to GLP/GMP standards

* Certified Lean Master Black Belt * Certified Six Sigma Black Belt * Leading Six Sigma and Lean Projects to deliver significant process and system improvement * Training, coaching & developing colleagues in six sigma / lean thinking, principles and skills * Leading and influencing operational excellence strategies and tactics * Promoting a culture of Continuous Improvement (CI) and process excellence * Achievements include the completion of multiple successful projects in areas such as QC test robustness, RFT end-to-end product delivery, batch review optimisation, QC documentation, DCS production recipe quality, maintenance work processes, strategy deployment (hoshin), OEE and supply planning