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
• Coordinate and lead team meetings related to production planning and batch release.

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

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

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

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
• 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
• 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