Alfonso Peña Torres Email & Phone Number

Boston, Ma, Us

Boston, Massachusetts, United States

- Responsible for managing the clinical product phase 3 readiness project across site. Site readiness was achieved at stablished date.-Responsible for the deployment of lean six sigma methodology across sites commercial process.-Supporting site need in responding to critical investigations and inspection responses.-Supporting site inspection readiness effort across site.-Supporting capacity modeling for comercial process-Project manager of key site portfolio projects

Toa Baja, Puerto Rico

• Coordinated cross-functional teams to successfully execute development projects, ensuring alignment of project goals and timelines with a timely completion of deliverables.• Develop and executed validation protocols for manufacturing equipment and facilities ensuring compliance with cGMP regulations and standing company procedures. • Developed and implemented a sitewide activity planner to coordinate all activities, including development, manufacturing, maintenance, and training amongst others. • Led project status meetings and provided regular updates to department heads and management, on project progress, risks, and issues around the site-plan.• Managed risk assessment and mitigation strategies, including risk identification, analysis, and contingency planning to ensure successful project outcomes. • Took the initiative to manage the completion of the assay method qualification for multiple analytical methods, ensuring their timely completion and developing the standardized test method with its respective subject matter expert. • Utilized project management software and tools to continuously create timelines, redundancies, and scenarios in a centralized location to ensure the site-wide communication and adherence to deliverables.

Manati, Puerto Rico

• Conduct and analyze process data to develop and execute initiatives for process improvements.• Bring together cross-disciplinarity teams when working on complex or recurring problems or perusing business opportunities. • Provide monthly projects updates to management, weekly update of project timelines and provide informal update of hurdles that will delay projects. • Lead and support Kaizen events across the site.• Launch and support simplification projects across site as per business need.• Manage SOP and Batch Record creation and revision. • Lead and support tier management redeployment across key workstreams. • Distribute Opex knowledge across site thru lean six-sigma, Tier management, problem solving, and lean leadership workshops across site.

Guayama, Puerto Rico

• Supervise and oversee 28 work centers, 10 manufacturing process and over thirty colleagues on 8hr and 12hr shifts. • Maintained staffing levels to meet load requirements.• Responsible for creating plans to meet future requirements.• Worked with management and engineering to improve any deficiencies.• Responsible that all safety, process, and company guidelines were adhered to and raised any concerns in these areas.• Monitor the efficiency of employees and implement the necessary plans to maintain the highest level.• Prevent and resolve quality problems generated in the workspace.• Manage quality events (deviations, investigations CAPAS) thru QTS Trackwise and SAP systems.• Ensure compliance with operational procedures (SOP) of your work area.

Guayama, P.R.

• Utilize six sigma tools to identify root-cause and control manufacturing deviations• Analyze the effectives of the corrective and preventives actions to determine the best course of action• Conduct and analyze process data to develop and execute initiatives for compliance improvements.• Design and implement systems to reduce human error and improve compliance to standard quality.• Provide monthly projects updates to management, weekly update of project timelines and provide informal update of hurdles that will delay projects.• Generate and perform temporary and permanent change request in Trackwise system.• Manage quality events (deviations, investigations CAPAS) thru QTS Trackwise and SAP systems.• Generate protocols.• Lead multitudinous training sessions across site.• Revise and design SOP’s and Production Batch Records• Support and provide insight to investigations thru root cause analysis, human error prevention and CAPA effectiveness.• Perform internal audits to ensure the SOP adherence.

Puerto Rico

• Assisting the engineering department in green-belt project management• Design and implement new project charter system• Provide monthly projects updates to management, weekly update of project timelines and provide informal update of hurdles that will delay projects. • Lead cross-site benchmarking activities to expedite the implementation of improvements• Perform cleanability assessment on new cleaning methods• Perform verification and validation protocols under the Material Exchange Committee.• Generate and perform temporary and permanent change request in QTS Trackwise system.• Manage quality events (deviations, investigations CAPAS) thru QTS Trackwise and SAP systems.• Revise and design SOP and Production Batch Records.

Puerto Rico

• Responsible for running the Integrated Manufacturing Excellence (IMEx) deployment for Manufacturing ecosystem (drug product) in granulation & dispensing and Capsule Filling areas.• Manage with due diligence activities of elements including visual management, standard work, continuous improvement loop and data driven performance.• Identify opportunities and implement changes to existing process to improve unit cost, yields, cycle time, and quality issues. • Lead root cause analysis for continuous improvement and definition of solutions for key defects.• Lead yellow and green belt projects with impact upon yield, cost avoidance and OEE (Overall Equipment Effectiveness).• Conduct and analyze process data to develop and execute initiatives for process improvements.• Lead cross-disciplinary teams when working on complex or recurring problems or pursuing business opportunities.• Provide monthly projects updates to management, weekly update of project timelines and provide informal update of hurdles that will delay projects.• Coach operators to set equipment to standard conditions and problem solving. • Support manufacturing areas by ownership of quality events investigations. • Generate temporary and permanent change request.• Generate request authorization to run at risk. • Manage quality events (deviations, investigations CAPAS) thru QTS Trackwise and SAP systems.• Analyze production data for the planning of budget and headcount

Puerto Rico

• Packaging line set up and maintenance• Aseptic handling of manufactured product • Packaging of vials & syringes • Documenting line procedure and processes