Najme Mohd Adli Email & Phone Number

Petaling Jaya, Selangor, Malaysia

-Validation Lead/IT Quality Validation for a major pharmaceutical MNC company.-Determines validation approach, identifies deliverables needed or impacted by a project/enhancement/change for GxP/non-GxP computerized systems.-Consulting, review and approve on quality of system and project deliverables, responsible for creating the validation related plans and reports and for carrying out the validation activities.-Review and approve Test Plan, Test Cases Pre- & Post-execution, Test… Show more -Validation Lead/IT Quality Validation for a major pharmaceutical MNC company.-Determines validation approach, identifies deliverables needed or impacted by a project/enhancement/change for GxP/non-GxP computerized systems.-Consulting, review and approve on quality of system and project deliverables, responsible for creating the validation related plans and reports and for carrying out the validation activities.-Review and approve Test Plan, Test Cases Pre- & Post-execution, Test Report using Application Lifecycle Management Tools and eDMS.-Advising on Software Testings with Good Documentation Practise, and also test deviations and issues resolution (CAPA, gap analysis,compliance issues).-Participate, review and approve system/ application changes/enhancement and/or bug fix releases documentations via Change Management Process. Show less

Bandar Baru Bangi, Selangor, Malaysia

•Responsible to lead and execute routine qualification activities (equipment, facilities, utilities) for Sterile Aseptic Line Manufacturing, ensuring compliance to GMP, ISO, PIC/S, PDA, WHO and other regulatory requirements.•Experienced in thermal validation systems involving autoclaves and depyrogenation tunnel/oven. Also executed Steam Quality Testing for pure steam system.•Co-lead and conducted Validation of Aseptic Processing (Media Fill) for sterile manufacturing line. Certified as… Show more •Responsible to lead and execute routine qualification activities (equipment, facilities, utilities) for Sterile Aseptic Line Manufacturing, ensuring compliance to GMP, ISO, PIC/S, PDA, WHO and other regulatory requirements.•Experienced in thermal validation systems involving autoclaves and depyrogenation tunnel/oven. Also executed Steam Quality Testing for pure steam system.•Co-lead and conducted Validation of Aseptic Processing (Media Fill) for sterile manufacturing line. Certified as Aseptic Processing Personnel bi-annually.•Executed and prepared protocols and reports for Equipment Qualification for tablets/capsule/oral suspension products. These includes blender, powder filling machine, capsulation machine & blistering machine.•Handled Process Validation (PV) for Sterile/Non-Sterile Products.•Jointly established Visual Inspector Qualification for manual inspection in injectable products (using Knapp test method).•Participation as auditee in Internal Audit (Internal Unit/Regulatory Compliance) & External Audit (NPRA). •Member in Quality Management System platform (TrackWise) for Change Control, Deviation and CAPA. Show less

Selangor, Malaysia

Handled and assisted in validation and qualification activities (IQOQPQ and PV) in a cleanroom (Sterile) Cephalosporin and non-sterile plant.Experienced in handling thermal validation and temperature mapping of depyrogenation Tunnel, dry heat ovens and autoclaves using Kaye Validation System. Also handled Steam Quality testing of Pure Steam Generator.Involved in establishing Visual Inspector Qualification program (using Knapp test method)

Selangor, Malaysia

• Produced catalogue of lab equipments under the name of Bioflow, as a marketing strategy for the company to further commercialize their products on online market through Exportersindia.com• Making price quotations as per my supervisor’s instructions when dealing with the clients’ request for quotation.• Created a logo for new company named Ayer Tech Sdn. Bhd. , water filtration project established under Fermetec Resources Sdn. Bhd. • Dealt with the stocks in store, by packing… Show more • Produced catalogue of lab equipments under the name of Bioflow, as a marketing strategy for the company to further commercialize their products on online market through Exportersindia.com• Making price quotations as per my supervisor’s instructions when dealing with the clients’ request for quotation.• Created a logo for new company named Ayer Tech Sdn. Bhd. , water filtration project established under Fermetec Resources Sdn. Bhd. • Dealt with the stocks in store, by packing, sealing and organising new stocks.• Made deliveries of products ordered by clients. Show less

Bachelor Of Science - Bs, Biotechnology

Activities and Societies: Member of Malaysian Students' Society Malaysia • Member of Linguistic Society •Undertook individual final year.

International Baccalaureate (Ib) Diploma

Activities and Societies: Korean Culture Club, Tennis Club, Student Volunteer, Community Service •Underwent community services to complete.