Bill Doyle Email and Phone Number

Technical Writing and Master Data Management for Medtronic Galway manufacturing facilities. Process and technology expert.Key Responsibilities- Lead department start-up across world facilities- Develop strategy and methodology for Technical Writing projects- Develop document strategy for new products and product transfers- Trouble shoot operator related CAPA actions and develop corrective actions- Error root cause analysis- Error reduction and elimination-… Show more Technical Writing and Master Data Management for Medtronic Galway manufacturing facilities. Process and technology expert.Key Responsibilities- Lead department start-up across world facilities- Develop strategy and methodology for Technical Writing projects- Develop document strategy for new products and product transfers- Trouble shoot operator related CAPA actions and develop corrective actions- Error root cause analysis- Error reduction and elimination- Configuration Management- Develop and control Master Data elements of SAP Manufacturing Execution System (SAP MES) Show less

Analyze and convert current state manufacturing instructions and Lot History Records into future state simplified documentation structure.Key Responsibilities- Lead Change Control for Device History Records- Lead cross functional review of manufacturing practice variances- Lead post conversion follow-up on documentation observations- Develop innovative solutions to technical requirements- Develop Pre and Post conversion metrics- Analysis of current state process… Show more Analyze and convert current state manufacturing instructions and Lot History Records into future state simplified documentation structure.Key Responsibilities- Lead Change Control for Device History Records- Lead cross functional review of manufacturing practice variances- Lead post conversion follow-up on documentation observations- Develop innovative solutions to technical requirements- Develop Pre and Post conversion metrics- Analysis of current state process instructions - Train technicians in analysis and technical writing skills Show less

Set-up and management of a drug formulation, polymer and drug coating area for a combination product medical device manufacturing facility. Area comprises of 2 shifts with approximately 400 direct employees. Key Responsibilities: - Department Set-up- Achieving Production, Quality and Financial targets- Interaction with QA/QC to develop and maintain quality standards- Implementation and maintenance of cGMP guidelines- Scheduling of material flow and manufacturing… Show more Set-up and management of a drug formulation, polymer and drug coating area for a combination product medical device manufacturing facility. Area comprises of 2 shifts with approximately 400 direct employees. Key Responsibilities: - Department Set-up- Achieving Production, Quality and Financial targets- Interaction with QA/QC to develop and maintain quality standards- Implementation and maintenance of cGMP guidelines- Scheduling of material flow and manufacturing through put- Process development and improvement- Supporting process and equipment validation- Support analytical laboratory function- Staff motivation and management- Internal Quality and cGMP auditing- Team lead and member of 6 sigma initiatives for process improvement and cost reduction- Process Trouble shooting- Conduct technical customer tours and regulatory body (FDA, BSI, IMP, TGA) audits- Generation of Quality and Manufacturing performance matrix Show less

Management of a two shift pharmaceutical processing and packaging facility and reporting directly to the general manager and managing director.Key Responsibilities: - Achieving Production, Quality and Financial targets- Scheduling – Material, manufacturing and shipment- Process development and improvement- Production trouble shooting- Department set-up- Interaction with QA/QC to maintain and develop quality standards- Implementation and maintenance of cGMP… Show more Management of a two shift pharmaceutical processing and packaging facility and reporting directly to the general manager and managing director.Key Responsibilities: - Achieving Production, Quality and Financial targets- Scheduling – Material, manufacturing and shipment- Process development and improvement- Production trouble shooting- Department set-up- Interaction with QA/QC to maintain and develop quality standards- Implementation and maintenance of cGMP guidelines- Process and equipment validation- Staff motivation and management- Reporting daily, weekly and monthly performance matrix- Reporting and Presentations to Parent Company- Managing complexity and change management- Internal quality and external supplier auditing- Liaise with regulatory affairs on Regulatory filings Show less