Summary
Overview
Work History
Education
Skills
Projects
Researches
Timeline
Generic

Homa Hasehzadeh

El Sobrante,USA

Summary

Seeking a position as a to leverage extensive experience in ensuring product excellence and process optimization.

Detail-oriented professional committed to improving organizational outcomes by monitoring performance initiatives. Focused on planning, implementing, and optimizing procedures. Specializing in operations and dedicated to maximizing quality.

I have 10 years of experience in quality assurance, regulatory affairs, and quality control within the pharmaceutical industry. Familiar with FDA, ICH, EMA guidelines, ISO 13485, 14000, 45001,9001.

Overview

8
8
years of professional experience

Work History

Mid-Senior Quality Assurance

Amin Pharmaceutical
Esfahan, Iran
12.2021 - 11.2023
  • Assured all quality related records generated by the company adhere to GLP/cGMP/GDM regulations
  • Provided training on Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to relevant personnel, ensuring they understood compliance regulations
  • Maintained the company’s training and continuing education program and records assuring that all personnel had the education, training, experience, to perform their job functions
  • Coordinated and responded to client quality questionnaires
  • Reported on the performance of the quality system to management
  • Conducted audits to ensure that new suppliers adhered to the company’s Quality Management System (QMS) and cGMP standards; rejected those with inadequate systems and inconsistent product quality
  • Maintained communication with suppliers to address quality deviations, ensuring thorough investigation of the root cause and implementation of corrective actions
  • Investigated Out-of-Tolerance/Out-of-Specification occurrences internally and externally to enhance quality standards
  • Achieved a significant reduction in quality issues/complaints/nonconformance from approximately 30 to around 6 cases per month, with notable improvements observed over several months, through regular quality meetings with suppliers and department managers, utilizing tools such as fishbone diagrams, 5W root cause analysis…, CAPA strategies, and training sessions
  • Reviewed deviation and change management processes and conducted evaluations on product quality, safety, and compliance with regulatory standards
  • Experienced in implementing necessary measures and actions to establish production lines for medical devices, ensuring compliance with ISO 13485 and FDA’s Quality System Regulation (QSR) while preparing essential documentation required for quality assurance

Quality Assurance (QA) Specialist

Amin Pharmaceutical
Esfahan, Iran
10.2017 - 12.2021
  • Identified and evaluated risks assessments in accordance with ICH regulations, held risk assessment meetings with stakeholders, followed up on topics that had been discussed in meetings, documented these proceedings, and communicated them to stakeholders, as well as assessed the effectiveness of meetings and their impact on risk mitigation
  • Prepared various critical documents, such as SOPs, VMPs, Quality Manuals, Batch Records, SMFs, Audit Reports, Customer Satisfaction Surveys, Inspection Checklists, and other QA-related forms and ensuring adherence to regulatory requirements
  • Reviewed GMP documentation, such as logbooks and production batch records, to ensure compliance with company policies and regulatory standards
  • Assisted in preparing documents for change control and deviations, participated in risk assessments and evaluations according to ISO 14971 and ICH Q10, and assessed how changes affect product quality, safety, and efficacy
  • Prepared CAPA form, identified problems, investigated and analyzed information, identified root cause, evaluated risk, held meeting with the CAPA board team, developed, verified and validated corrective action and/or preventive action and communicated results with involved parties
  • Conducted and managed periodic product quality reviews (PQR), analyzed production and quality control data to identify trends and deviations, ensured product compliance with regulatory and internal standards, prepared comprehensive PQR reports, and proposed necessary improvements to maintain and enhance product quality (follow 21CFR Part 211 and ICH Q7/Q10)
  • Managed and executed cleaning validation activities to ensure the complete removal of residues, contaminants, and microbial agents
  • Led process validation efforts to ensure the stability and uniformity of high-quality product manufacturing
  • Prepared validation documents and analyzed data to ensure compliance with regulatory standards and requirements, in accordance with FDA regulations (21 CFR Part 211) and ICH guidelines (Q7 and Q10)
  • Conducted and managed GMP inspections to ensure compliance of manufacturing processes with regulatory standards, specifically in accordance with FDA regulations (21 CFR Part 210 and 211) and ICH guidelines (Q7 and Q10)
  • Evaluated and analyzed documentation and production processes to identify areas for improvement
  • Prepared detailed reports of inspection findings and recommended corrective and preventive actions to address deficiencies
  • Collaborated with various teams to maintain and enhance continuous compliance and quality

Regulatory affairs specialist

Amin Pharmaceutical
Esfahan, Iran
12.2016 - 10.2017
  • Released finished products following comprehensive review of laboratory and production documentation
  • Obtained and issued product licenses in compliance with regulatory requirements
  • Conducted daily and weekly inspections to ensure compliance with GMP principles and prepare discrepancy reports for management and relevant departments

Quality Control Specialist

Amin Pharmaceutical
Esfahan, Iran
12.2015 - 12.2016
  • Performed various quality control tests throughout the manufacturing process
  • Prepared detailed work instructions for performing dissolution, hardness, friability, leakage, and thickness testing according to the latest ICH Q4 dissolution testing, ICH Q3A hardness testing, ICH Q3B friability testing, ICH Q1D leakage testing, and ICH Q3A thickness testing guidelines
  • Monitored and enforced relevant manufacturing standards and regulations

Education

MS - Genetics Molecular and Cellular Biology

Nouredanesh University
Isfahan, Iran

B.S. - Molecular and Cellular Biology

Nouredanesh University
Isfahan, Iran

Skills

  • Quality Risk Management (QRM)
  • Quality Management System (QMS)
  • Cleaning and process validation
  • Product Quality Review (PQR)
  • Change Control
  • Document management
  • Corrective and Preventive Action (CAPA)
  • Non-Conformance Event (NCE)
  • Software: Tableau
  • Microsoft Office Suite (Word, Excel, PowerPoint, Visio, OneNote)
  • Strong troubleshooting and problem-solving
  • Process Mapping,Regression Analysis,SWOT,PESTLE,The Five Whys,Histograms,Control Charts,Pareto Charts,Cpk,Cp
  • Supplier Evaluation,Audit

Projects

Technology Transfer Management of Production, Amin Pharmaceutical Company, Servier Pharmaceutical Company, Apotex Pharmaceutical Company

Researches

Nouredanesh University Laboratory, Studied the effects of changes in genes VKORC1 (rs99233231), CYP2C9 (rs1799853 & rs1057910) on drug administration in the Iranian ethnic group.

Timeline

Mid-Senior Quality Assurance

Amin Pharmaceutical
12.2021 - 11.2023

Quality Assurance (QA) Specialist

Amin Pharmaceutical
10.2017 - 12.2021

Regulatory affairs specialist

Amin Pharmaceutical
12.2016 - 10.2017

Quality Control Specialist

Amin Pharmaceutical
12.2015 - 12.2016

MS - Genetics Molecular and Cellular Biology

Nouredanesh University

B.S. - Molecular and Cellular Biology

Nouredanesh University

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Homa Hasehzadeh