# Noura Samy Emara - Compliance Specialist
Source: https://hello.cv/noraomara
Quesna

## Links
- LinkedIn | https://www.linkedin.com/in/noura-samy-emara-3434a2275?utm_source=share_via&utm_content=profile&utm_medium=member_android
- Email

## 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
### Compliance Specialist | SIGMA pharmaceutical industries
Manages comprehensive compliance operations within a pharmaceutical manufacturing environment, ensuring adherence to quality and regulatory standards.
- 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 | Science

## Languages
- Arabic
- English

## Certificates
### Online course covering the fundamental principles and practices in quality manufacturing processes
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)

## Source
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