Henry Arevalo

Reviewed batch records for various manufacturing stages, including media preparation, upstream and downstream manufacturing, and final fill, ensuring adherence to industry standards and CFR. Conducted investigations and CAPA reviews to maintain quality assurance in biological clinical and commercial facilities.

Conducted pharmaceutical investigations to identify root causes of failures in products, processes, and instruments, ensuring compliance with global regulatory bodies. Assessed the impact of failures on product quality attributes, safety, and efficacy.

Performed batch record reviews for media preparation, upstream and downstream manufacturing, and final fill, ensuring compliance with industry standards and CFR. Generated and reviewed documentation, investigations, and CAPAs for biological facilities producing cell proteins.

Conducted protocol-driven retro reviews for an aseptic company in India to assess the proper writing of customer complaint investigations and product safety. Performed similar reviews for a medical device leader in the USA to ensure FDA compliance of past investigations and product releases.

Reviewed and approved testing and releases of processed human tissue, including skin and eye grafts, for a medical device and human cell technology leader. Red-lined Standard Operating Procedures and suggested improvements in Documentation and Quality Assurance Departments, adhering to CFR title 21 Part 1271.

Conducted primary reviews of products manufactured in an aseptic environment in India for import into the United States, ensuring compliance with master batch record requirements and industry standards. Evaluated manufacturing and testing deviations, wrote investigations and procedures, and coached production and quality personnel.

Supported packaging validation remediation activities for an OTC pharmaceutical company, facilitating cross-functional alignment with Operations, Quality, Project Management, and Engineering. Authored and executed Packaging PQs and PPQs Protocols and reports, created Validation and Commercial Batch records, and reviewed Cleaning Validation Protocols.

Provided QA oversight of manufacturing and packaging activities for oral solid dose pharmaceuticals, focusing on Good Documentation Practices. Managed unplanned events, deviations, batch/production records, equipment cleaning, and line clearance documentation.

Oversaw tech transfers for OTC products, attending third-party meetings to manage logistics and regulatory compliance. Responsible for the transfer and validation of new products/processes, auditing facilities, and generating/reviewing validation protocols for processes, equipment, and cleaning.

Reviewed and released batch records for finished products and implemented Standard Operating Procedures for finished product releases and in-process systems, translating them into Spanish. Conducted cGMP training programs to enhance quality awareness and compliance for shipping products to USA and Canada.

Led the qualification and requalification of production equipment, including packaging lines, and participated in utilities qualification for compressed air and clean/process steam systems. Developed and prepared Risk Assessments, Impact Assessments, Gap Assessments, Qualification Plans, and Validation Master Plans.

Managed manufacturing and packaging areas for various pharmaceutical products, including transdermal patches, bottling lines, and secondary packaging lines. Scheduled production personnel, monitored documentation and batch record review, and ensured GMP compliance, training, and safety.

Supervised manufacturing and packaging areas for various pharmaceutical products, including transdermal patches, bottling lines, and secondary packaging lines. Ensured compliance with regulatory and state requirements, investigated process discrepancies and customer complaints, and planned and executed SOPs, GMPs, and Safety Training.

Improved site processes, products, equipment, and procedures using Total Quality Management and Industrial Engineering tools. Performed internal pre-approval and post-approval inspections for ANDAs and NDAs, and internal audits of facility departments.

Supervised solid dosage operations, powder products, packaging, and scheduling to maintain quality and production output. Created SOPs and Investigation Reports in a cGMP environment, designed and conducted training programs, and participated in the development of Qualification protocols for packaging lines.

Supervised line auditors inspecting and monitoring product quality in the Soft gel production line. Originated and implemented Standard Operating Procedures, involved in approvals and review of batch records and Protocols for Equipment Qualifications.

Supervised the receiving, testing, accountability, specifications, storage, and releases of labels and labeling material to production. Created PQ's and IQ's protocols, Process and Cleaning Validations for the production department, and led numerous validation processes and equipment validations.

Studied Engineering Management at Florida International University. This program focused on the intersection of engineering and business principles, preparing for leadership roles in technical fields.

Completed a Bachelor's degree in Industrial and Systems Engineering. The curriculum covered optimizing complex processes, systems, and organizations, with a strong emphasis on efficiency and productivity.

Earned an Associate in Science degree in Electronics Technology. This program provided foundational knowledge and practical skills in electronic systems and their applications.