Karim Mostafa Aboshamaa
Quality Assurance Directorate at Pharco Corporation
Bolkly, Alexandria, EgyptWork Experience
Quality Assurance DirectorateFull Time
Pharco Corporation
Dec 2024 - Present -6 months
- Job Details:Responsibilities -Leading all quality assurance functions and aligning activities with cGMP and GDP standards. -Coordinating internal audits, implementing CAPA plans, and optimizing quality systems. -Collaborating with manufacturing and regulatory teams to ensure product release compliance. -Managing quality documentation and ensuring compliance with industry regulations.
QHSE ManagerFull Time
Integrated Cosmetics industry (Parkville Pharmaceuticals)
Jun 2024 - Dec 2024 -6 months
Egypt , Alexandria
- Job Details:Responsibilities -Overseeing QHSE systems and promoting a culture of continuous improvement. -Conducting risk assessments, root cause analyses, and corrective action activities. -Establishing SOPs and compliance documentation aligned with ISO standards. -Training and mentoring staff on QHSE protocols, reducing non-conformance incidents.
QHSE ManagerFull Time
El- Nasr Company for edible gelatin.
Sep 2023 - May 2024 -8 months
Egypt , Alexandria
- Job Details:Responsibilities -Managing quality and safety systems in a regulated food-grade production facility. -Monitoring hygiene practices, validating critical processes, and training staff. -Standardizing procedures under ISO 22000, GHP, and HACCP requirements. -Collaborating with R&D to ensure new products meet quality and safety standards.
Quality Assurance Section HeadFull Time
European Egyptian for pharmaceutical industry
May 2016 - Aug 2023 -7 yrs, 3 months
Egypt , Alexandria
- Job Details:Responsibilities -Supervising QA operations, including deviation handling and internal documentation. -Leading change control processes, supplier qualification, and batch review procedures. -Enhancing compliance levels through internal audits and system updates. -Fostering collaboration across teams to streamline processes and resolve quality issues.
Education
Professional Diploma in Analytical Biochemistry
Faculty of science, Alexandria university, EgyptJan 2015 - Jan 2016 - 1 Year
Bachelor's Degree in Science
Alexandria University (ALEXU)Jan 1997 - Jan 2001 - 4 yr
High School - Thanaweya Amma
Mohammed koraiem high schoolJan 1997
Achievements
Led successful GMP and ISO 9001/22000 certifications across multiple sites with zero critical observations. Reduced non-conformance rates by 35% through strategic implementation of CAPA and root cause analysis protocols. Streamlined QA/QHSE systems, resulting in a 25% improvement in audit readiness and regulatory compliance. Established and standardized over 100+ SOPs, enhancing operational efficiency and documentation integrity. Directed cross-functional teams through internal and supplier audits, improving supply chain quality by 40%. Implemented risk-based quality strategies, significantly reducing deviation recurrence and batch failures. Led validation of new production lines, ensuring flawless regulatory inspections and successful product launches. Integrated ERP systems (Oracle/SAP) with QA/QHSE workflows, increasing process tracking and traceability by 50%. Reduced product rejection rates by 30% through enhanced in-process control and real-time monitoring.
Skills
- ISO 9001
- Change Management
- Risk Management
- Quality Assurance (QA)
- QHSE management
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- ISO 9001:2015
- ISO 22000
- Total Quality Management (TQM)
Languages
Arabic
FluentEnglish
Fluent
Training & Certifications
IRCA 9001:2015 Lead Auditor
Arab Academy for Science and Technology and Maritime Transport·2023ISO 9001:2015 Lead Auditor
Arab Academy for Science & Technology·2023Professional Diploma in Total Quality Management (TQM)
Arab Academy for Science & Technology·2022Lean Six Sigma Green Belt (LSSGB)
Professional Management Expertise Center·2019Clinical biochemistry diploma
Alexandria university·2016