Daniel R. Email & Phone Number

Mexico City, Cdmx, Mx

Mexico City, Cdmx, Mx

Mexico

Technical Support Engineer focused on ensuring the quality and safety of pharmaceutical products through process optimization and training personnel in the use of specialized software.Responsibilities:- Perform technical support and validation activities for systems, equipment, and processes, ensuring compliance with Good Manufacturing Practices (GMP).- Develop and execute validation protocols (IQ, OQ, PQ) to ensure that pharmaceutical systems and processes meet regulatory and quality requirements.- Collaborate with quality, production, and IT teams to optimize workflows, enhance operational efficiency, and ensure business continuity.- Supervise and support internal and external audits, as well as prepare the necessary documentation to ensure regulatory compliance.- Identify opportunities for continuous improvement in validation processes and regulatory implementation, contributing to operational excellence and risk minimization.Key Skills:- Advanced knowledge of implementing and managing regulatory standards such as FDA, EMA, and COFEPRIS.- Proficiency in the use and support of specialized software for quality management and validation in the pharmaceutical industry.- Effective communication skills for training and technical advisory to users at all organizational levels.- Ability to identify and mitigate risks associated with validation and regulatory compliance, ensuring the quality and safety of pharmaceutical products.Key Achievements:- Successfully implemented validation programs in high-impact projects, achieving 100% compliance with regulatory standards and exceeding expectations in external audits.- Developed validation protocols that improved operational efficiency and reduced implementation time by 25%.- Trained multidisciplinary teams in the use of validation software, increasing accuracy and consistency in quality processes

Naucalpan De Juárez, México, México

My specialization involves implementing improvement projects to standardize analytical methodologies and associated documentation, ensuring efficient processes and compliance with quality standards. Responsibilities: Local Project Management: Lead and coordinate projects with local teams, ensuring alignment with project objectives and efficient execution of assigned tasks. Documentation Updates: Maintain and update technical documentation, specifications, and action plans to reflect the latest changes and improvements in processes. Quality Management: Oversee quality investigations and processes, as well as manage the Daily Management System and Master Validation Plan within the laboratory to ensure compliance with established standards. Regulatory Compliance: Perform tasks in accordance with ISO requirements, internal policies and procedures, as well as national and international safety regulations. Product and Procedure Audits: Collaborate in product and procedure audits to ensure that quality and compliance with regulatory and corporate standards are maintained. Cost Organization and Management: Organize and manage project costs, identifying opportunities for resource optimization and generating operational savings. Achievements: Improved Methodologies: Standardized analytical methods, enhancing documentation efficiency and consistency. Cost Savings: Achieved significant operational savings through effective cost management. • NOM-059-SSA1-2015 (MÉXICO).• NOM-164-SSA1-1998 (MÉXICO).• GMP Guildelines Health (CANADA).• Guide to Good Manufacturing Practices for medicinal products (EUROPA).• CFR 21• Report 44, 45 OMS Pharmaceutical GLP • NOM-073-SSA1-2015

Naucalpan De Juárez, México, México

Analytical chemist with experience in raw material analysis, seeking to apply technical skills and knowledge in a challenging environment to contribute to quality assurance and process development, implementing Good Sampling Practices. Responsibilities: Application of Good Sampling Practices:Apply good sampling practices to ensure sample quality. Inspection of Containers and Documents: Inspect containers and associated documents for each sample. Monitoring and Reporting:** Monthly monitoring and reporting of temperature and humidity levels. Sample Analysis: Analyze raw material samples. Equipment Handling: Operate RAMAN TruSCAN and Rap ID equipment.

Lerma, México, México

Pharmaceutical development of new products, reformulations, and establishment of strategic supplier relationships with innovative and cost-effective solutions. Responsibilities: Formulation and Manufacturing: Formulate and manufacture pilot batches. Process Transfer: Transfer formulation processes. Development of Procedures: Develop change control procedures. Preparation of Formulas: Prepare master formulas and manufacturing formulas. Pharmacopeias and Standards Handling: Handle pharmacopeias and ISO 9001-2015 standards.

Tultitlán, México, México

Supported research on fluorine products and low global warming potential refrigerant gases of the new generation, following the A1 classification of the ASHRAE SSPC34 committee. Responsibilities: Analytical Equipment Handling: Use of HPLC, GC, UPLC, and ICP-OES. Protocol and Report Preparation: Create protocols and reports for analytical methods. Strategic Planning: Plan, create, and coordinate the global strategy for controlling product quality. KPI Identification: Identify key performance indicators (KPIs) that influence product quality.

Tultitlán, México, México

Contributed to the development of the "LYRA sanguine pencil for export to Europe and the USA" through product and process design, scaling, technology transfer, and validation stages. Responsibilities: Formula Design: Design the formula and select materials. Pilot Formula Development: Develop the pilot formula and manufacture pilot batches. Transfer and Scaling: Transfer technology, produce transfer batches, and make critical modifications. Validation: Confirm critical quality and process attributes

Diploma Of Education, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, Diplomado Aseguramiento De La Calidad Farmacéutica

Auditor Interno En La Industria Farmacéutica, Regulacion Farmaceutica

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Lic. Quimica, Química Orgánica. Síntesis De Moléculas Orgánicas

Desarrollo, síntesis y diseño de nuevos fármacos asistido por computadora (DIFAC) diseño que se emplea para formalizar, eficientar y.