Rahimi Asri

1. Point of contacts for quality-related inquiries & complaints [Non-conformance Notification (NCN), Supplier Corrective Action Request/Report (SCAR/CAR)] 2. Liaison with customers and functional teams to understand the quality expectations & update on resolution progress 3. Enforce of Quality Management System (QMS) aspects per EN ISO 13485:2016, USFDA 4. Develop & monitor effectiveness of Quality Control Plan [Critical to Quality (CTQ), Critical Control Point (CCP)] 5. Oversee and approved Device History Record (DHR) documents [IPQC Report, Outgoing Inspection Report, Line Clearance Report] Projects Involvement 1. Smart Cables Establishment (PC1Q, PSC2) 2. Dock-to-Stock Project (Nov 2024 – Dec 2024)

1. Monitor and evaluate defects at source (Root Cause Analysis, data extraction) 2. Failure Analysis & Investigation 3. Identify opportunities to support cost & quality improvements. 4. Scrap Rate analysis 5. Management of products and Process Validation (Trial run, experiments) 6. Tracking, coordinating and follow up on Field Investigation, Corrective and Preventive Actions (CAPA) and procedures. 7. In-line process management liaison with Process Technician & Operators on process parameters, raw materials, and products specification.

1. Responsible for quality system planning, implementation of cGMP in plant & maintain compliance of manufacturing activity with regulatory requirements [Line Clearance (LC), Environment Monitoring System (EMS), as per SOPs & Batch Record] 2. Parts of Audits & keep the department under total cGMP compliance. 3. Responsible to generate and review SOPs & Qualification documents [Process Validation (PV) Protocol/Report, Cleaning Validation (CV) Protocol/Report, Process Qualification (PQ) Protocol/Report] 4. Responsible for performing In-Process checks [Disintegration Test (DT), Friability, Tablet Testing] & to collect In-Process samples, Control samples, Finish Goods (FG) samples, Stability samples & Validation samples. 5. Responsible in ensuring Good Documentation Practices (GDP) in master production records, review & assess [Batch Manufacturing Record (BMR)/Batch Packaging Record (BPR)] as per compliance. 6. Execution of Cleaning Validation (CV) activities (sampling, data recordings/compilations, reports) 7. Execution of Process Qualification (PQ) as per protocols (Blister Packing Line, Encapsulation)

1. Responsible in project progress, schedule & source arrangement for plant maintenance 2. Execute static cleaning (Hydro blasting) & mechanical static works [Heat Exchanger (HEX) extraction, heavy lifting, Air Fin Cooler (AFC) maintenance] 3. Responsible on Non-Destructive Test (NDT) results and mitigation plan on projects [Dummy Probe, Internal Rotary Inspection System (IRIS), Eddy Current Test (ECT)] 4. Liaison with client & sub-contractor on site preparation, project progress & safety compliance at site 5. Execute workflow (information extraction, preparation of equipment, mobilised- demobilised, manpower loading)