Senior Process & QA Specialist cGMP Expert

Fareeda Sherif Ghanem

• +20-011******** *************@*****.*** Villa 25F, Sunrise Compound, Fifth Settlement, New Cairo, Egypt.

Experience

-Senior Process Specialist 11/2024 - Present Novartis.

-Process Specialist 10/2021 -11-2024 Novartis.

• Managing a diverse team to ensure that daily operations are compliant with cGMP, HSE & Novartis standards.

• Project manager for process optimization projects and continuous improvement initiatives. ( Led a project for capacity optimization)

• Deviations and complaints handling and CAPA management as a certified deviation owner and investigator.

• Execute and ensure good documentation practices GDP are implemented.

• Review and approve the manufacturing documents (e.g. filled batch record, deviation reports, logbooks etc...) within the process unit to ensure continuous operational running.

• Issuing and updating manufacturing documents (master batch records) MBRs and SOPs.

• Support in execution of firmed finite schedule according to lean principles to achieve agreed upon KPI's process unit to ensure continuous operational running.

• Execute and review SAP & lean related activities.

• Delivery of technical training to team through different methodologies (OTJ, classrooms) as a certified GXP trainer.

• Issuing process validation protocols, reports and ensuring that validation activities for new launches and legacy products are carried out on-time according to the site’s validation master plan SVMP.

• Participating in the implementation of Change Control management

• Issuing equipment qualification documents URS, FRA, SRA through (DQ, IQ, OQ, PQ).

• GMP coordinator, plan and follow up on GMP walk-through (define frequency, team members, areas).

• Data integrity SPOC in PU, ensuring documents and systems are complying with DI standards

-Stability Analyst -Analytical Science & Technology-Quality Assurance 10/2020 - 10/2021 Novartis.

• Perform stability analysis as assigned in accordance with Novartis standard and ICH requirements

(FUST, commitment and accelerated).

• Receive samples for stability enrollment and initiation of stability notification before samples storage.

• Commitment to applicable GLP, DI and HSE guidelines as appropriate while conducting activities in AS&T Lab.

• Reporting stability results and issuing of stability reports as required.

• Preparation of stability data for registration dossier.

• Initiate and support investigation in case of analytical deviation and OOS/OOT incidence.

-Nutrition Advisor Intern 07/2017 - 09/2017 Nestle.

• Worked at Pediatric clinics, raised awareness about toddler's nutrition and healthy eating habits.

• Communicated with mothers, listened to their concerns, and recommended them a healthy diet plan that suits their toddlers.

• Promoted for Nestle's infant formula.

-Clinical Chemistry Laboratory intern 07/2017 - 07/2017 Children cancer hospital 57357 Skills

• Supervisory Skills · Quality Management · Change Management · Six Sigma · Presentation Skills · Project Management · Problem Solving · Change Control · Lean Process Improvement · Communication Skills · Team Management · Good Manufacturing Practice (GMP) Quality · Corrective and Preventive Action (CAPA). Project Plans · Operations · Regulatory Requirements · Key Performance Indicators. Training. Process improvement. Education

Total Quality Management Diploma Arab Academy for Science & Technology 02/2023

The Basic Six Sigma Breakthrough Improvement Process

Statistical Quality Control Standards for Quality Management System

Managing the Quality Functions Project Management Pharmacy German University in Cairo 06/2019

• Attended the semester abroad program for W'17/18 at the GUC campus in Berlin. GPA status: very good.

High School Diploma Egyptian Language School 06/2014

• GPA Status: Excellent

Certifications

Green Belt-Six Sigma -2026

Pharmaceutical GMP Professional Certification CPGP-ASQ-2025 Inspectors Academy-Novartis- 2024

Google Project Management Certificate -2023

Brand Management Aligning business, brand, and behavior. London Business School 01/2020

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