RT
Ramy Mostafa Taha
QA Validation & Qualification Manager at Glaxosmithkline
Maadi, Cairo, EgyptWork Experience
QA Validation & Qualification ManagerFull Time
- Job Details:• Governance of QA validation strategies for systems, operations, Pharma & Combination products • Develop Validation department budget & KPI’s to measure performance, Providing necessary metrics monthly for reporting to management board • Support site technical team for updating products registration files for submission to regulatory body • Develops, review and approve validation lifecycle documentation for site projects as per GSK policies & regulatory guidelines • Participating in section audits from a disclosure point of view, to ensure effective CAPA is applied where required • Responsible for identifying risks and escalate to risk management process owner, develop risk mitigation plan and Coordinates validation activities with other site departments • Quality CAPEX projects follow-up responsible • GSK functions project, Kaizen & continues improvement team member • Liaises with other departments with validation status/ requirements • Assists with New Products manufacturing processes – applies knowledge & experience • Assist in the implementation of Product Life Cycle management through Process Validation & Continued Process Verification • Conduct site staffs’ validation training as required
QA Change ManagementFull Time
Aug 2019 - Aug 2020 -1 yr
Saudi Arabia , Jeddah
- Job Details:• Lead, oversight & communicate change management process & CCRs actions follow up • Regulatory inspection readiness team member, responsible for quality preparedness plans • Lead & manage change & compliance activities for handling & producing medical devises/combination products at site • GDP site responsible • Site training lead, responsible for oversight of training activities for all site colleagues
Quality compliance LeadFull Time
Aug 2016 - Jul 2019 -2 yrs, 11 months
Saudi Arabia
- Job Details:• Lead, communicate & manage internal audit program • Participates in external audits of potential new/existing contract manufactures, contract distribution centres • Review, communicate & follow-up quality KPI’s/quality metrics & quality improvement plan • Point of contact for responses to corporate/governmental audit observations • Oversees Saudi FDA regulatory commitments • Site regulatory inspection readiness & CAPA follow up SME • MENA region sites corporate inspection readiness support • Site Risk Management program SME • Management review board coordination • Monitor/Oversight local SOPs compliance system adherence to corporate policies, global & local regulatory guidelines as part of regulatory intelligence program • Support registration team for products registration /localization files review before submission to SFDA • Follow up with registration team on the submitted files for approval through registration trackers • Provides training/training presentation documentation pertaining to employee learning curriculum, industry guidance document, SFDA inspections
QA (Validation/Qualification) supervisorFull Time
Sep 2015 - Aug 2016 -11 months
Saudi Arabia , Jeddah
- Job Details:• Manage validation Projects during site start-up phase & Saudi FDA inspection with cross functional teams of different operation groups • Review, communicate and maintain commissioning and qualification projects plans, in addition to computerized systems validation plans (CSV) • Manage all local transportation routes validation & warehouse thermal mapping activities • Review & communicate commissioning & qualification projects protocols for facilities, utilities & equipment protocols in preparation for site start-up • Manage all packaging validation activities following Saudi FDA site approval • Training for newly hired team members for cGMP, GDP, validation activities • Technology transfer projects team member, providing technical support during process transfer & optimisation
validation section headFull Time
- Job Details:- EMEA accreditation preparation team member, responsible for all validation/qualification related activity - Establish, develop, communicate and sustain validation strategy, master plan and requalification schedules - Establish, update, and maintain validation programs for equipment and utilities commissioning and qualification, equipment cleaning validation, computer systems validation (CSV) , process validation & process improvement - Work with Operations and R&D Groups to establish, develop, communicate and maintain a validation assessment plan for all GXP assets, buildings, systems, including laboratory instrumentation and systems - Work with Operations members to perform risk assessment plans for all products processing & cleaning activities using risk assessment tools (FMEA, FMECA, FTA, etc...) - Preparation of performance qualifications for various production equipment - Responsible for thermal validation for warehouse as part of GSP - Supplier qualification team member
validation section headFull Time
- Job Details:- EMEA accreditation preparation team member, responsible for all validation related activity - Establish, develop, communicate and sustain validation strategy, master plan and requalification schedules - Establish, update, and maintain validation programs for equipment and utilities commissioning and qualification, equipment cleaning validation, computer systems validation (CSV) , process validation & process improvement - Work with Operations and R&D Groups to establish, develop, communicate and maintain a validation assessment plan for all GXP assets, buildings, systems, including laboratory instrumentation and systems - Work with Operations and other QA members to perform risk assessment plans for all products processing & cleaning activities - Preparation & implementation of performance qualifications for various production equipment - Responsible for thermal validation for warehouse as part of GSP - Part of annual product review preparation team for various products - Supplier qualification team member - CAPA team member - ISO 9001 internal audit team member
Education
Master of Quality Management in quality management
Arab Academy for Science, Technology and Maritime Transport (AAST)Jan 2016 - Jan 2023 - 7 yr
Bachelor's Degree in pharmacy
Ain Shams University (ASU)Jan 1997 - Jan 2002 - 5 yr
Achievements
Pfizer site startup
Skills
Languages
English
FluentFrench
Intermediate