Hamdan Mohd Isa Email & Phone Number

Hamdan Mohd Isa is a Validation Engineer at PharmEng Technology at PharmEng Technology. He is proficient in English.

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  Validation Engineer

  Pharmeng Technology

  Apr 2013 - Present - Malaysia

  Develop the validation / qualification protocols / test script prior to the qualification of equipment, utilities, facilities (Installation, Operation & Performance). This include of Technology Transfer programme. Review initial documents for validation /qualification equipment purposes such as URS, FDS, Business Impact Analysis (BIA), Risk Assessment and other related/ required documents.• Responsible for CSV Compliance, preparing Validation Plan (VP) and planned execution scheduled. o Validation Plan includes the details of the validation activities that will be initiated for the affected computerized system/ equipment. o Experienced in developing the CSV ‘V’ model approach and able to plan the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to meet the industrial standard and complying with the CFR Part 11. o Experienced in qualifying production equipment and include requirement from t 21 CFR Part 11 for Electronic Records and Electronic Signature (ERES) Requirements under the Computer System Validation (CSV) • Writing, review and remediation of validation protocols and report writing. • Provide assistance and advice to System Owner on the Risk Assessment (i.e HLRA, QNA, CGMP FRA, 21 CFR Part 11 Assessment, HS&E Assessment) prior to start the validation/qualification activity. • Provide assistance to project manager or system owner to meet the project time-lines, implementation and control of weekly basis execution, operational and for validation final report approval. • Handling the decommissioning / retirement activity including preparation of documentation, protocol, execution and report. • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc. • Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP/FDA/EU). Complete assigned projects and tasks within agreed deadlines