Certified ISO 9001 QMS lead auditor CQI|IRCA. (May 2023)
Key Learnings
- plan and implement a QMS within an organization, including establishing policies, objectives, and processes that align with the organization's goals and objectives.
- Documentation and record-keeping: create and maintain documentation that demonstrates the organization's compliance with quality management standards.
- Monitoring and measurement: establish and implement monitoring and measurement processes, including the use of key performance indicators (KPIs).
- Nonconformities and corrective actions: identify nonconformities, evaluate their impact, and develop and implement corrective actions.
- Auditing and continuous improvement: conduct audits,
identify areas for improvement, and develop and implement recommendations for continuous improvement.
Certificate in GDP (Good Distribution Practice) from Whitehall.
(August 2022)
Key Learnings
- Gained an understanding of the regulatory requirements related to GDP and the importance of complying with these requirements.
- Cold chain management: the importance of cold chain management and the measures that need to be taken to ensure that products are transported and stored under the appropriate conditions.
- Quality management systems: the key elements of a QMS,
including documentation, training, change control, and corrective and preventive actions.
- Risk management: learned about the various risks that can impact the distribution process, such as temperature excursions, theft, and damage, and the importance of risk assessment and mitigation.
- Good documentation practices: record keeping, batch traceability, and product labeling
Work Experience
CSL Behring Business Partner in Egypt
August 2012 - Present
QPPV | Quality Manager
Quality Responsibilities
- Ensure compliance with Good Storage Practice (GSP), Good
Distribution Practice (GDP) and other applicable regulations related to quality, safety, and efficacy of drugs.
- Oversee all quality systems and processes within the storage and distribution operations, including warehouse and inventory management, transportation, and supply chain.
- Develop and implement quality policies, procedures and work instructions for storage and distribution activities.
- Investigate and resolve quality-related issues and customer complaints related to storage and distribution.
- Review quality data and metrics to identify potential risks and opportunities for improvement.
Manage and investigate product deviations and nonconformances to ensure they are resolved properly according to procedures and regulations.
- Review and approve customer and internal complaints,
investigate root causes, and implement corrective and preventative actions to resolve issues and improve processes.
- Maintain quality deviation and change control records and documents, and ensure they comply with applicable regulations and standards.
- Review and approve process changes to ensure compliance with quality standards and procedures.
- Define the structure of documentation, establish systems of control, and ensure accurate and up to date documentation.
- Train staff on quality procedures and ensure they are properly qualified and competent to perform their roles.
- Create and maintain documentation related to quality management systems such as Standard Operating
Procedures, calibration and maintenance records, audit reports, etc.
- Continuously improve the quality management system to ensure it is effective and meets business requirements.
- Develop and maintain systems to measure performance against established standards.
- Responsible for handling audits conducted on our quality department from global site.
