Fathirol Atif Zainal Abidin

Experience

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  Malaysia Nuclear Agency

  Jul 2012 - Sept 2012

  Internship Student

  Project Research on Vulcanization of Radiation of Natural Rubber Latex in making a baby tip

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  Shimano

  Jun 2013 - Aug 2015

  Product Development Assurance (PDA) Engineer

  • Responsible for plans, directs and coordinates manufacturing processes by providing technical support in the development implementation and maintenance of manufacturing methods • Initiate and prepare all process i.e. control plan, jig and tools for SOP running based on FMEA study• Ensure documents readiness, created process layout, develop work instruction and provide training to operators.• Generate BOM and submit for agile released

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  Teleflex Incorporated

  Sept 2015 - Dec 2016

  Process Engineer

  • Improving (reduction) operational cost of existing operation by means of quality, productivity and efficiency improvement for PVC product.• Troubleshoot daily process issue to sustain product quality, yield and delivery.• Undertaking qualification/verification/validation of new process, new material and new equipment.• Supporting failure/complaint/EIF/CAPA investigation and recommend its solution for corrective action to prevent recurrences.• Drive the proactive quality activities and introduce process control (poka yoke) Show less

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  Hovid Bhd

  Jan 2017 - May 2021

  Validation Engineer

  • Oversee validation and qualification activities for various facility, utility system i.e. purified water, compressed air, HVAC and production equipment.• Protocol and report preparation, coordinate validation and qualification activities (IQ/OQ/PQ) for pharmaceutical facilities, critical utilities and equipments used in manufacturing process.• Work planning for Validation Technician pertaining to day to day validation activities.

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  Pharmaniaga Berhad

  May 2021 - Jun 2023

  • Authorized as 2nd person in the absent of Head of QA to review and approve document pertaining cGMP or those that have impact on product quality.• Authorized as Quality Executive to review batch record and release finished product using SAP system for commercial.• Analyze any deviation or non-conformance cases of the affected finished product batches prior to closure.• Review all validation and qualification documents related to sterile and non-sterile plant including facilities, utilities and equipment.• Coordinate and prepare the yearly product quality review (PQR) report.• Handling complaint/recall by coordinate and liaise with other department for proper investigation and report submission. Show less

  • Sr Quality Assurance Executive

    Jun 2022 - Jun 2023

  • Sr Technical Services Engineer

    May 2021 - Jun 2022
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  BD

  Jul 2023 - now

  Quality Engineer II

  • Perform process validation work, by writing protocol, executing the protocol, performing data analysis, and writing report. Review and comment the validation protocols & report issued by other departments.• Be a validation independent reviewer and technical independent reviewer for process validation protocol & report. Review process validation data generated and performed statistical analysis and sampling where appropriate.• Lead measurement system analysis for acceptability and coordinate test method validation activities.• Employs techniques like six sigma, lean manufacturing for operation improvement.• Responsible for the issuance of product item number and bill of material for Finished products.• Coordinate and work with production and process partner for CAPA investigation, analysis and documentation.• Be a QA representative who participate in R&D Transfer Project and Plant to Plant Transfer Project.• Assist Quality Manager/Unit Manager/Quality Senior Manager in carrying out any special project or assignment. Show less