Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
Generic
Alexander Silva Clausi

Alexander Silva Clausi

Sarasota,FL

Summary

Químico Farmacéutico con más de 10 años de experiencia en la industria farmacéutica, especializado en Control de Calidad, Validaciones y cumplimiento regulatorio. Amplio manejo de normativas BPL, BPM, GAMP5 y sistemas integrados de gestión (ISO 9001, ISO 14001, ISO 45001). Liderazgo técnico, gestión de equipos multidisciplinarios y orientación a resultados.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Jefe de Control de Calidad

CIFARMA S.A.C.
01.2022 - 12.2024
  • - Dirección integral del área de Control de Calidad (Fisicoquímico, Microbiología e Instrumentación).
  • - Gestión de más de 100 colaboradores.
  • - Liiderar equipo de certificacion ante auditorías DIGEMID e INVIMA.
  • Optimized testing methodologies to cover broader range of defects with quicker detection times.
  • Reduced turnaround time for quality concerns by establishing efficient communication channels between departments.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Collaborated with cross-functional teams to identify potential areas of improvement in production processes, leading to enhanced product quality.
  • - Reorganización de subáreas de Fisicoquímico y Microbiología.
  • - Creación del área de Validación de Sistemas Computarizados.
  • - Implementación de sistemas documentales digitales.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.

Supervisor de Control de Calidad

CIFARMA S.A.C.
01.2017 - 12.2021


  • - Participación en auditorías exitosas para certificación BPL DIGEMID e INVIMA.
  • Trained workers in different departments in improved procedures designed to enhance quality and eliminate errors.
  • Supervised and directed quality control personnel through effective mentoring, coaching and work delegation.
  • Supported audits and led teams to fully investigate quality control processes and root out deficiencies.
  • Evaluated employee performance regularly, providing constructive feedback and coaching aimed at skill development and career growth opportunities.
  • Streamlined production efficiency by optimizing quality control procedures for maximum output.
  • Maintained testing equipment in good working order to effectively quality control [Type] production lines.
  • Enhanced product quality by implementing rigorous inspection processes and protocols.
  • Created and implemented strategies for improving operational efficiency and accuracy.
  • Planned, organized and monitored resources to deliver efficient use of labor, equipment and materials.

Jefe de Control de Calidad

LABORATORIOS UNIDOS S.A.
10.2015 - 12.2016
  • Spearheaded root cause analysis investigations when needed, determining underlying issues and recommending appropriate fixes.
  • Participated in regular management review meetings, providing updates on quality control performance and suggesting areas for improvement.
  • Conducted regular audits of production facilities, ensuring compliance with industry standards and regulations.
  • Used [Software] to produce reports regarding daily production quality, nonconformance of products or processes and quality trends.
  • Established a system for tracking non-conformances, facilitating quick resolution and preventing future occurrences.
  • Increased customer satisfaction with comprehensive quality assessment strategies.

Diversos cargos en Control de Calidad

Medrock Corporation S.A.C.
03.2011 - 03.2015
  • - Participación en certificación BPL 2014.
  • - Gestión de área de HPLC, validaciones y análisis.
  • Excellent communication skills, both verbal and written.
  • Proven ability to learn quickly and adapt to new situations.
  • Worked effectively in fast-paced environments.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Organized and detail-oriented with a strong work ethic.

Education

Bachelor of Science - Pharmaceutical Sciences

UNIVERSIDAD SAN LUIS GONZAGA
ICA, PERU
02-2011

Skills

  • Risk mitigation strategies
  • Client satisfaction management
  • Quality control methodologies
  • Process optimization

Accomplishments

  • Supervised team of 100 staff members.
  • Colaborado con un equipo de 10 personas en la implementación del proyecto de Validacion de Sistemas Computarizados del laboratorio de Control de Calidad.
  • Liderar el proyecto de renovación del laboratorio de control de calidad (CIFARMA).


Certification

  • DIGEMID – Perú
  • - Certificación BPL (Fisicoquímico y Microbiología) – 2019-11 – Supervisor – CIFARMA
  • - Recertificación BPL (Fisicoquímico y Microbiología) – 2024-11 – Jefe – CIFARMA
  • INVIMA – Colombia
  • - Certificación BPL Fisicoquímico – 2020-07 – Supervisor – CIFARMA
  • - Certificación BPL Microbiología – 2020-11 – Supervisor – CIFARMA
  • - Certificación BPL – 2014 – Técnico – Medrock Corporation
  • - Certificación BPL – 2023 – Asesor – Laboratorio de Biofarmacia de Corporación Portugal (Arequipa)

Languages

English
Professional Working

Timeline

Jefe de Control de Calidad

CIFARMA S.A.C.
01.2022 - 12.2024

Supervisor de Control de Calidad

CIFARMA S.A.C.
01.2017 - 12.2021

Jefe de Control de Calidad

LABORATORIOS UNIDOS S.A.
10.2015 - 12.2016

Diversos cargos en Control de Calidad

Medrock Corporation S.A.C.
03.2011 - 03.2015

Bachelor of Science - Pharmaceutical Sciences

UNIVERSIDAD SAN LUIS GONZAGA

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