About
Highly detail-oriented Compliance Specialist with comprehensive experience in the pharmaceutical industry, adept at navigating complex regulatory frameworks. Proven ability to manage deviations, change controls, and investigations, ensuring strict adherence to quality and regulatory requirements. Committed to driving compliance, mitigating risks, and enhancing operational effectiveness through meticulous root cause analysis and CAPA implementation.
Work
SIGMA pharmaceutical industries
|Compliance Specialist
Quesna, Menoufia, Egypt
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Summary
Manages comprehensive compliance operations within a pharmaceutical manufacturing environment, ensuring adherence to quality and regulatory standards.
Highlights
Managed and closed multiple deviations on time, ensuring proper root cause analysis and effective CAPA implementation to maintain regulatory compliance and operational continuity.
Participated actively in internal and external audits, identifying critical gaps and implementing corrective actions to significantly improve GMP compliance across departments.
Conducted rigorous risk assessments using QRM tools like FMEA, proactively identifying potential issues and mitigating operational risks to enhance product safety and quality.
Streamlined CAPA tracking and follow-up processes, achieving timely closure and enhancing overall effectiveness of corrective actions by ensuring accountability.
Supported and facilitated change control processes, ensuring smooth implementation with minimal disruption to product quality and regulatory compliance.
Effectively handled customer complaints and investigations, ensuring timely resolution and thorough documentation to uphold product integrity and customer satisfaction.
Coordinated and supported product recall activities, ensuring meticulous documentation and adherence to regulatory requirements, minimizing brand impact.
Ensured strict adherence to Good Documentation Practices (GDP) and Data Integrity (ALCOA+) standards, maintaining robust compliance across all operational records.
Education
Benha University
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Bachelor
Science
Languages
Arabic
English
Certificates
Online course covering the fundamental principles and practices in quality manufacturing processes
Issued By
Udemy
Skills
Attention to Detail
Attention to Detail.
Problem Solving
Problem Solving.
Time Management
Time Management.
Teamwork
Teamwork.
Microsoft Office
Microsoft Office.
Communication Skills
Communication Skills.
GMP Compliance
GMP Compliance.
Deviation & Investigation Handling
Deviation & Investigation Handling.
CAPA Management
CAPA Management.
Change Control
Change Control.
Root Cause Analysis
Root Cause Analysis.
Data Integrity (ALCOA+)
Data Integrity (ALCOA+).
Internal Audits
Internal Audits.
Risk Assessment (FMEA)
Risk Assessment (FMEA).