Ruhan A

Experience

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  Abbott Nutrition NL

  Nov 2012 - Aug 2017

  During this period, include one year rotation to the Manufacturing department.  Computerized system Track-Wise Project Lead:Abbott Nutrition division QM project, propose is Non-conformance and CAPA management digitalization in AN Jiaxing site. Change Control Management (M-Files system):Organize the regular site Change Control Meeting. Review the proposed change request (CR) and ensure that the relevant SMEs have fully evaluated the CR before approval to the implementation phase. Non-conformance & CAPA management (GQMS system):Make sure all the nonconformity are proper handled according to the Abbott quality procedure, the RCA is carried out according to the risk level, the disposition of the impacted product is appropriate and reasonable, and CA/PAs are effectively implemented to prevent quality problems from recurring. Consumables Management:Serve as the site contactor for AN Medical Safety and Regulatory Affairs, make sure the Consumables/expendables that have potential for direct/indirect product contact, get the Chemical Safety Approval (CHEMSA) before purchase and usage. Show less Assigned to the Manufacturing department to rotate for one year. Develop the process of regular on-line GMP walk down, build the on-line inspection team in manufacturing department. Review and approval the manufacturing SOPs, and do the gap analysis for the manufacturing procedure with the Abbott Nutrition policy, define the risk mitigation plan, ultimately ensure that the compliance risk is eliminated. Initiate new SOP for On-line rejection management (include product and packaging material), and train all the Abbott shop floor operators and contractors in filling and packaging area. Oversee the operators’ activities are strictly follow the Abbott procedure especially performing a Line Clearance and Line Start-up & Verification. Conduct regular training to Shop-floor operators, including GMP, GDP and Hygiene knowledge, assess the effectiveness of training. Train packaging contactors on the manual packaging line, and ensure that contractors operate in accordance with Abbott standard work instructions. Show less Report to QA Manager (Foreigner - Malaysian) Qualification and Validation: Participated in Qualification & Validation training in Abbott Nutrition Singapore site in 2015.Responsible for clean utility and equipment validation, e.g. nitrogen distribution system, compressed air distribution system, IGW/RO water system, HVAC.Supported validation system migrations in 2015. M-Files Commissioning and Validation Management (CVM) application is used as a new IT tool which replaced the previous validation system. Established the basic process of M-Files system for Jiaxing plant.  Change Control Process Optimization:Based on the functional roles and responsibilities of new organization, develop the Change Impact Assessment Checklist by each department. Initiate a new management platform - Change Board Meeting for change control process. Change Control Process Digitalization:Transfer M-Files system into Abbott Jiaxing site, make the change management process from paper based into computerized system. Deviation & CAPA management:Make sure all the nonconformity are proper handled according to the Abbott quality procedure, the RCA is carried out according to the risk level, the disposition of the impacted product is appropriate and reasonable, and CA/PAs are effectively implemented to prevent quality problems from recurring. Consumables management:Serve as the site contactor for AN Medical Safety and Regulatory Affairs, make sure the Consumables/expendables that have potential for direct/indirect product contact, got Chemical Safety Approval (CHEMSA) before purchase and usage. Show less Part І Project Phase: Lab equipment IOPQ, and Micro lab SOP initiation Test method transfer and method validation Supported clean utilities system qualification and validation, including purified water, compressed air, clean steam, clean nitrogen, etc.  Established environment monitoring plan for manufacturing areaPart ІӀ Commercial production phase: Raw material/ Packaging material release testing Microbiology testing of finished product Routine environmental monitoring and Clean utility system monitoring Show less

  • Quality Assurance Supervisor

    Apr 2017 - Aug 2017

  • Quality Operation Supervisor

    Feb 2016 - Apr 2017

  • Quality Assurance Engineer

    Aug 2014 - Jan 2016

  • Micro lab Analyst

    Nov 2012 - Jul 2014
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  罗氏公司

  Aug 2017 - now

  Engineer Lead

  Joined in Roche Diagnostic Suzhou site, Quality & Regulatory Department, from August 2017. :- During the project phase, establish the essential QMS processes, based upon the regulatory requirement of Medical Device China GMP, ISO 13485 and Roche Diagnostic (RD) divisional standards.- Build the interface with the related stakeholders in other Roche organization. - Responsible for all the quality issue handling during process validation within projects, support the clinical chemistry product and Elecsys product transfer from RDG to RDSZ.- SAP P1U NC Project Leader in RDSZ- Established several Divisional Procedure within Roche Diagnostic- Nonconformance/ CAPA/ OOS Management - Logistic claim for product shipment between China and Germany Show less