Krupal Patel, Ms Cscp Email & Phone Number

Mason, Oh, Us

Wilmington, Ohio, United States

• Production planning of three (3) proprietary and one (1) client products.• Create and publish short and long-term production plans and schedules from ERP (SAP)/forecasts.• Collaborate with multiple teams to manage production schedules, product release plans, material inventory, and procurement of materials.• Highlight risks and critical issues impacting product manufacturing and supply (S&OE).• Coordinate and lead team meetings related to production planning and batch… Show more • Production planning of three (3) proprietary and one (1) client products.• Create and publish short and long-term production plans and schedules from ERP (SAP)/forecasts.• Collaborate with multiple teams to manage production schedules, product release plans, material inventory, and procurement of materials.• Highlight risks and critical issues impacting product manufacturing and supply (S&OE).• Coordinate and lead team meetings related to production planning and batch release.• Develop and maintain supply chain metrics such as, On Time In Full (OTIF), backorder status, and schedule adherence.• Manage timely closure of action items in production planning and release cycle.• Actively participate and lead the alliance partner relationships for monthly supply planning and coordination meetings with clients, track performance, and proactively identify supply disruptions and risks.• Master Data Management (MDM) and Bill of Materials (BOM) management.Operational cost reduction by analyzing and streamlining SC processes. Show less

Wilmington, Ohio, United States

• Certified Operational Excellence Practitioner (Green Belt Holder). • Collaborated and supported various departments to ensure regulatory compliance.• Led the development of cleaning processes (Automated and Manual) for various manufacturing equipment.• Authored media simulation (media fill) and process validation (PPQ/CPV) documents for aseptic manufacturing processes.• Managed cleaning requalification programs for manufacturing equipment.• Integrated of Quality into… Show more • Certified Operational Excellence Practitioner (Green Belt Holder). • Collaborated and supported various departments to ensure regulatory compliance.• Led the development of cleaning processes (Automated and Manual) for various manufacturing equipment.• Authored media simulation (media fill) and process validation (PPQ/CPV) documents for aseptic manufacturing processes.• Managed cleaning requalification programs for manufacturing equipment.• Integrated of Quality into Manufacturing by utilizing Quality by Design concepts during the initial process development phase.• Generated validation and verification protocols, technical reports, validation risk assessments, change control, batch records, SOPs, and task trackers.• Performed statistical process analysis utilizing JMP®.• Supported process and site improvement projects. Show less

Wilmington, Ohio, United States

• Certified Operational Excellence Practitioner (Green Belt Holder). • Collaborated and supported various departments to ensure regulatory compliance.• Led the development of cleaning processes (Automated and Manual) for various manufacturing equipment.• Authored media simulation (media fill) and process validation (PPQ/CPV) documents for aseptic manufacturing processes.• Managed cleaning requalification programs for manufacturing equipment.• Integrated of Quality into… Show more • Certified Operational Excellence Practitioner (Green Belt Holder). • Collaborated and supported various departments to ensure regulatory compliance.• Led the development of cleaning processes (Automated and Manual) for various manufacturing equipment.• Authored media simulation (media fill) and process validation (PPQ/CPV) documents for aseptic manufacturing processes.• Managed cleaning requalification programs for manufacturing equipment.• Integrated of Quality into Manufacturing by utilizing Quality by Design concepts during the initial process development phase.• Generated validation and verification protocols, technical reports, validation risk assessments, change control, batch records, SOPs, and task trackers.• Performed statistical process analysis utilizing JMP®.• Supported process and site improvement projects. Show less

Decatur, Illinois

• Project manager for multiple aseptic equipment projects such as Depyrogenation Tunnels, Autoclaves, and Incubators.• Managed project initiation, planning, execution, monitoring, controlling, and closing.• Collaborated with multiple key stakeholders to achieve project milestones.• Implemented GEMBA walks, Kanban board, and Kaizen concept for multiple departmental tasks.• Supervised contractors and consultants working on multiple projects.• Reviewed and approved Validation… Show more • Project manager for multiple aseptic equipment projects such as Depyrogenation Tunnels, Autoclaves, and Incubators.• Managed project initiation, planning, execution, monitoring, controlling, and closing.• Collaborated with multiple key stakeholders to achieve project milestones.• Implemented GEMBA walks, Kanban board, and Kaizen concept for multiple departmental tasks.• Supervised contractors and consultants working on multiple projects.• Reviewed and approved Validation documents such as protocols and technical summary reports.• Performed gap and data analysis on existing processes and prepared remediation plans. Show less

Fort Washington, Pa

• Provided consultation for consent decree remediation efforts by collaborating with external auditors.• Planned and managed manufacturing activities for multiple shifts.• Trained team members on various manufacturing processes.• Process mapping of consumer product manufacturing.• Performed equipment Operation and Performance Qualification (OQ/PQ) for various equipment such as Girton and Belimed parts washer.• Generated protocols and technical reports for various cGMP.

Swiftwater, Pennsylvania

• Provided consultation on aseptic manufacturing equipment’s cleaning process development and validation.• Identified the worst-case product (Protein/Vaccine) for equipment cleaning from the product portfolio utilizing different experimental studies and analysis of test data.• Achieved resource cost reduction for the client by implementing efficient equipment cleaning processes.• Supported quality investigations, and root cause analysis, and implemented CAPA (Corrective and… Show more • Provided consultation on aseptic manufacturing equipment’s cleaning process development and validation.• Identified the worst-case product (Protein/Vaccine) for equipment cleaning from the product portfolio utilizing different experimental studies and analysis of test data.• Achieved resource cost reduction for the client by implementing efficient equipment cleaning processes.• Supported quality investigations, and root cause analysis, and implemented CAPA (Corrective and Preventative Action). Show less

Fort Washington, Pennsylvania

• Provided consultation for consent decree remediation efforts by collaborating with external auditors.• Planned and managed manufacturing activities for multiple shifts.• Trained team members on various manufacturing processes.• Process mapping of consumer product manufacturing.• Performed equipment Operation and Performance Qualification (OQ/PQ) for various equipment such as Girton and Belimed parts washer.• Generated protocols and technical reports for various cGMP.

Kankakee, Il

• Performed various process and cleaning validation activities including the creation of protocols and final reports at a startup plasma manufacturing plant.• Led cleaning validation executions on multiple plasma manufacturing equipment such as Girton Washers, Buffer Tanks, Fractionation Tanks, and Buffer Tanks.

Swiftwater, Pa

• Provided consultation on aseptic manufacturing equipment’s cleaning process development and validation.• Identified the worst-case product (Protein/Vaccine) for equipment cleaning from the product portfolio utilizing different experimental studies and analysis of test data.• Achieved resource cost reduction for the client by implementing efficient equipment cleaning processes.• Supported quality investigations, and root cause analysis, and implemented CAPA (Corrective and… Show more • Provided consultation on aseptic manufacturing equipment’s cleaning process development and validation.• Identified the worst-case product (Protein/Vaccine) for equipment cleaning from the product portfolio utilizing different experimental studies and analysis of test data.• Achieved resource cost reduction for the client by implementing efficient equipment cleaning processes.• Supported quality investigations, and root cause analysis, and implemented CAPA (Corrective and Preventative Action). Show less

West Point, Pa

• Reviewed, authored, and approved cleaning validation protocols and reports for equipment from aseptic/sterile injectables manufacturing areas.• Supported execution of steam-in-place (SIP), clean-in-place (CIP), and clean-out-place (COP) studies on various equipment.

Brookhaven, Ny

• Quality control testing of oral solid drug products (tablets and capsules) using HPLC, UPLC, and Karl Fischer instruments.• Testing method transfer from research and development to quality control laboratories.• Carried out statistical analysis of test data.

Master Of Science, Pharmaceutical Manufacturing Engineering

Bachelor Of Science, Pharmaceutical Sciences