• Lead multi-disciplinary project teams with overall responsibility of the assigned projects. Developed and improved project management tools as required. • Created comprehensive project plans, budgets, objectives, strategies, and deliverables to ensure successful project execution. • Implemented contingency plans to mitigate unforeseen events and changes in strategy. • Managed new product launches, ensuring all filling and launch targets were met within established timelines. • Translated project plans into measurable actions, executing against functional procedures and processes. • Maintained compliance with regulatory agencies, functional systems, ethics policies, and project goals. • Managed stakeholder engagement through effective communication and relationship-building.

• Led multi-disciplinary project teams, overseeing all aspects of assigned projects. • Developed and enhanced project management tools to optimize project execution. • Developed project charters, conducted risk assessments, and established comprehensive project plans, including objectives, milestones, resources, costs, and critical issues. • Identified and mitigated project risks and issues, ensuring key milestones were achieved. • Coordinated team activities and facilitated effective communication among team members. • Provided regular updates on project progress to senior leadership and reviewed business development proposals.

Responsible for Charactrization, Optimization, Scale up, New product Launches, Alternate Resources, Technical Transfers, Process Improvements and troubleshooting of solid and liquid oral dose products.Responsible for the various validation activities as they relate to Process, Packaging and Cleaning of the highest quality and meet all applicable SOP's and regulatory standards.Write and review the validation protocols and respective reports for any process, packaging, hold time and cleaning validation activities in the company.Support of commercial product in compliance with current regulations and standards.Oversee and perform necessary validation activitiesAssist senior management in investigations to determine the root cause and to place appropriate CAPA.Initiate and track any applicable change controls with respect to validation activities.Perform internal audits as required and assist in any regulatory audits at the company and provide the necessary support.Create and revise SOPsAssisted in the completion of IQ/OQ/PQ, needed to qualify the equipment needed for the validation studies.Created and revised Master Batch Records, SOPs, and Change Controls.Performed process troubleshooting and product impact analysis.Established the clean and dirty equipment hold time and revised the Enviremental tracking program.

• Managed the production, packaging and the maintenance teams.• Prepared production and packaging schedule and executed as planned. • Reviewed product demand forecasts, change requests, and contracts to ensure that the necessary criteria and provisions are included in product selection.• Developed and executed strategies to improve the safety in the plant.• Planned and oversaw of the expansion and modernization of the production department and Established the packaging department• Conducted regular Operational Improvement Reviews and created a Preventative Maintenance program to improve production efficiency and reduce down time and production cost.• Participated in non-conformance failure analysis activities. • Ensured company requirements are adequately addressed within the supply base.• Maintained effective and timely communications with key functional team members (QA/QC/ planning and shipping) regarding new product introductions during the execution phase. • Established new training programs for all plant’s employees, improved the existing fire evacuation and fire safety plans. in compliance with OSHA regulations, while leading the emergency response team.

• Responsible for all aspects of product development/ validation, including submission, pilot runs, scale-up trials, process validation as well as packaging and cleaning validations.• Managed a diverse team across multiple department and shifts to finish the projects assigned on time.• Being the subject matter expert, I was involved in everyday activities in the production department and performing clinical investigations, process deviations reports, and implementing the necessary Corrective and Prevention Actions (CAPA). • Wrote validation protocols and reports that are complying with Good Manufacturing Practices (CGMP), Standard Operation Procedures (SOP), and Food and Drug Administration (FDA) requirements• Responsible for new product Launches, Alternate Resources, Technical Transfers, and Process Improvements. • Assisted in the completion of IQ/OQ/PQ, needed to qualify the equipment needed for the validation studies.• Created and revised Master Batch Records, SOPs, and Change Controls. • Performed process troubleshooting and product impact analysis.

• Responsible for performing Challenges testing, troubleshooting, data entry, packaging validation processes, and assisting scientist in product validation.• Prepared and revised Master Batch Records, Packaging Batch Records, protocols, Validation and Equipment Qualification documents.• Initiated CCRs and communicated changes to regulatory personal. • Issued stability study reports on monthly basis. • Followed safety and health programs and associated plans.

Responsible for coordination, integration, initiation of the raw materials specifications due for correction or creation.Write material specification and change control documentation in GSS and Symphony for the projects.Responsible for gathering required information, follow up with suppliers and provide support to optimize the team's effectiveness. Prioritize workload, handle multiple tasks simultaneously and meet deadlines.Establish and maintain files, records and documents in an organized fashion.

 Troubleshoot the problems that occur in the plants and discuss the result to the process engineers and R&D  Special projects and accomplishment : o Inline NIR project.o Validation for new Equipment and machines.o Minimizing leakage on the line during filling by 88%.o Soft solid leakage formulation project.o Train and manage the New Co-ops.

Analyzed daily Case Fill Rate research/analysisMaintained daily sales report by brand by month; Compare against ConsensusPrepared a Shade Splits Analysis (Monthly)Updated prop factors and generate reports, reviews expiration issues and dispositionWorked with Quality and Distribution Centers to remove inventory holds and blocks.Updated inventory Projection, audit Vendorville accuracy, and support Well Dress Measure process.

Prepared and produced pilot scale batches of antiperspirants, deodorants and gels for R&D and consumer testing.Conducted a formulation design study to incorporate a new cost-effective raw material and improve product performance.Updated standard operating procedures (SOPs) for pilot plant equipment.Executed quality tests on antiperspirant products to ensure release specifications were met.Operated drum lifts, heat exchangers / thermutator, cooling tunnel, mixing agitators, mixing tanks, filling machine, compressors, and viscometers. Performed weekly and monthly calibration on Lab equipment