MARWA HAFEZ AHMED
Sterile Area Manager
Alexandria
Summary
Dynamic operations manager with a proven track record of enhancing organizational efficiency through innovative employee motivation strategies and rigorous policy enforcement. Expertise in industry best practices and regulatory compliance ensures alignment with operational goals and standards. Results-driven leader leveraging analytical skills to develop strategic business plans and effectively tackle daily challenges. Committed to fostering a collaborative work environment that drives team performance and achieves measurable outcomes.
Overview
16
16
years of professional experience
14
14
Certifications
3
3
Languages
Work History
Manager of Sterile Production Lines
PHARAONIA PHARMA
10.2023 - Current
- Current Responsibilities:
- lead batch sterility assurance by complete implementation of the validated procedure of media fill, cleaning validation and personal monitoring through contact and finger prints' records and continual training.
- Lead the qualifications of the Visual inspection process including Knapp- kushner validation and daily challenge tests of filled glass containers to ensure batch safety.
- Schedule a time frame with engineering department for equipment's requalification.
- Establish quality metrics to ensure the validity of aseptic processing.
- Fulfill the required marketing plan with a suitable and adequate time necessary for complete batch analysis prior release.
- Oversee the entire daily production process, ensuring adherence to schedules, quality standards, and safety protocols.
- Monitor production lines for potential issues and implement corrective actions to optimize resources.
- Lead production staff- providing training, mentoring, coaching, and performance feedback- to achieve targets.
- Conduct risk assessments and implement plans to mitigate potential contamination risks.
- Track and analyze production data to identify areas for improvement and optimize efficiency.
- Collaborate with other departments (e.g., engineering, maintenance) to ensure optimal equipment performance and uptime.
- Work closely with the Quality Assurance department to ensure compliance with Good manufacturing Practice (cGMP) and internal quality standards.
- Review and approve batch records, production documents, and deviations.
- Manage staff performance, providing constructive feedback and coaching for development.
- Address employee concerns and maintain high morale within the team.
- Contribute to budget planning and cost control initiatives.
- Managed and motivated employees to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
- Cross-trained existing employees to maximize team agility and performance.
- Managed budgets effectively, ensuring optimal financial performance.
Deputy Manager of Non-Sterile Production Lines
PHARAONIA PHARMA
10.2020 - 09.2023
Head of Solid Production
PHARAONIA PHARMA
10.2017 - 09.2020
Head of Liquid and Semi-solid
PHARAONIA PHARMA
10.2015 - 09.2017
Pharmacist
PHARAONIA PHARMA
10.2009 - 09.2015
Education
Master of Science - Pharmaceutical Sciences
University of Alexandria
Alexandria 04.2001 -
Skills
Experience with sterile and non-sterile processes
Pharmaceutical process technologies
Global regulatory standards proficiency
Strong analytical and execution skills
Experience in risk evaluation
Quick decision-making in scientific contexts
Budget management and financial literacy
Cleanroom layout design
Process validation proficiency
Aseptic validation
Efficient documentation framework
Strong technical computer skills
Strategic leadership experience
Certification
April 2021 Advanced GMP – (Egyptian Drug Authority “EDA”)
References
Ahmed, Amer, Dr., ahmedame@oslomet.no, +47 46562428, Oslo Metropolitan University, Teaching Assistant
Publications
- Developing a formula for a new treatment approach for OLP.
- Manifestation for the work was published on January 2020 on Journal of “ORAL DISEASES” and “WILEY” under the name of Selenium: A sole Treatment for erosive Oral lichen Planus (Randomized-Controlled Clinical Trial)
Timeline
Manager of Sterile Production Lines
PHARAONIA PHARMA
10.2023 - Current
Deputy Manager of Non-Sterile Production Lines
PHARAONIA PHARMA
10.2020 - 09.2023
Head of Solid Production
PHARAONIA PHARMA
10.2017 - 09.2020
Head of Liquid and Semi-solid
PHARAONIA PHARMA
10.2015 - 09.2017
Pharmacist
PHARAONIA PHARMA
10.2009 - 09.2015
Master of Science - Pharmaceutical Sciences
University of Alexandria
04.2001 -