Nelson Alejandro Fierro
Las Calandrias 4514. B° Las Acacias. Colonia Avellaneda. Entre Ríos
Summary
Strategic, organized Quality Professional with more than 24 years of experience achieving organizational excellence in pharmaceutical industry. Excellent leadership and communication skills integrated with analytical abilities to determine areas for potential improvement. Continuously evaluated and improved quality for clients working for the most important Pharmaceutical multinational companies.
Overview
26
26
years of professional experience
Work History
Quality Director
ERIOCHEM S.A.
04.2010 - Current
- Established and maintained quality standards for non-sterile API manufacturing and Sterile Finished Products for human use.
- Executed internal GMP audits to measure grade of compliance with applicable regulatory requirements.
- Executed supplier audits for APIs, primary and secondary packaging material.
- Determined quality department standards, practices, and procedures.
- Established and tracked quality department goals and objectives.
- Tracked quality issues with external customers, suppliers, and internal plant operations.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Applied coaching techniques and tools to support managers and team members in improving performance.
- Implemented new quality assurance and customer service standards.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Executed quality assurance initiatives to implement Quality Oversight and Quality Culture Programs.
- Defined Quality KPIs, objective values and support managers to maintain in compliance or implement corrective/preventive actions for negative trends.
- Prepared Action Plans in front of announced regulatory inspections and acted as inspection team leader.
- Supported area managers to define affective corrective actions for internal/external audits and regulatory inspections.
- Performed escalation of critical issues to Board of Directors.
- Defined Quality Technical Agreements with customers and suppliers.
- Prepared and executed Audit programs covering self-inspections, quality inspections and supplier inspections.
Quality Assurance Manager
ERIOCHEM S.A.
02.2000 - 05.2010
- Performed root cause analysis to identify and resolve quality issues and defects.
- Created and maintained quality management systems to align with industry standards.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Monitored staff organization and suggested improvements to daily functionality.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Reported production malfunctions to managers and production supervisors.
- Worked closely with management teams to plan, develop and execute technical strategies aligned to client's vision.
- Supported implementation of warehouse management system software applications to enable centralized management of tasks.
- Prepared training plans for QA staff.
- Approved procedures, product and components specifications, validation master plans, qualification and validation protocols and reports.
- Supported inspection/audit teams
- Reported Quality KPIs periodically.
- Prepared Annual Product Reviews for each manufactured products.
- Implement GMP programs and Quality Risk Assessment methodologies.
Professor
Córdoba National University
08.1999 - 02.2000
- Prepared practical laboratory experiments of Medicinal Chemistry.
- Participated in periodic test of knowledge of pharmacy students.
External Consultant
MEGLINE S.A.
10.1999 - 12.1999
- Collaborated with Technical Director to define, strategize, and implement improvements for the first ANMAT regulatory inspection.
- Reviewed quality system procedures to handle deviations, complaints, recalls, non-conforming product, OOS results, etc.
Technical Direction - Production Manager
LAFEDAR S.A.
05.1998 - 07.1999
- Standardized production procedures, job roles, and quality assurance guidelines.
- Managed internal operational standards and productivity targets.
- Sourced materials to keep up with production goals and meet customer demands.
- Wrote and conducted formal performance reviews for production personnel.
- Created and oversaw production schedules and adjusted as needed to meet deadlines.
- Monitored inventory levels and restocking schedules to avoid production delays from unavailable materials.
- Coordinated with other departments to align production with customer requirements.
- Implemented quality control system to review products against technical specifications and corporate standards.
- Performed batch record review and released product to the market.
- Performed internal audits to QC labs.
- Prepared responses to the Health Authorities related with submitted dossiers of medicinal products for human use.
- Received regular GMP inspections.
IPC Analyst
UNC Blood Derivates Laboratory
03.1997 - 05.1998
- Managed time efficiently in order to complete all tasks within deadlines.
- Analyzed samples from different steps into the manufacturing process of fractioning of human plasma proteins.
- Calculate the amount of the reagents to be added into the process based on the IPC results.
- Followed the applicable SOPs.
Education
Quality Engineering Specialist -
National Technological University
Santa Fe - Argentina12.2006
Bachelor in Pharmaceutical Sciences -
National University of Cordoba (UNC)
Haya De La Torre Esq. Medina Allende. (5000) CBA.12.1996
2nd Lieutenant (Army Reserve Officer) - Infantry
"General Paz" Military High School
Av. Juan B. Justo S/N. (5019) Córdoba12.1988
Skills
- Quality Management Systems
- Risk Management
- Team Development
- Tracking Metrics
- Knowledge of Auditing Systems
- Key Performance Indicator Development
- Inspection Procedure Implementation
- Training Initiatives
- Strategy Management
- Train Staff
- Compliance
- Customer Satisfaction
Affiliations
SAFyBI (Argentinean Society of Industrial Pharmacy and Biochemistry)
Timeline
Quality Director
ERIOCHEM S.A.
04.2010 - Current
Quality Assurance Manager
ERIOCHEM S.A.
02.2000 - 05.2010
External Consultant
MEGLINE S.A.
10.1999 - 12.1999
Professor
Córdoba National University
08.1999 - 02.2000
Technical Direction - Production Manager
LAFEDAR S.A.
05.1998 - 07.1999
IPC Analyst
UNC Blood Derivates Laboratory
03.1997 - 05.1998
Quality Engineering Specialist -
National Technological University
Bachelor in Pharmaceutical Sciences -
National University of Cordoba (UNC)
2nd Lieutenant (Army Reserve Officer) - Infantry
"General Paz" Military High School
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