Assed H.

Experience

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  ADNOC Group

  Aug 2004 - Dec 2004

  Project Co-ordinator

  • Management of 3 teams, consisting of 4 members per team• Preparation of Standard Operating Procedure documentation to be followed on the project defining the responsibilities of each team member• Briefing Team Leaders on how to apply the Materials Policy to the inventory project• Training personnel to use PDA Software for recording inventory running on Palm OS• Reporting the teams’ daily performance to the Project Manager• Acting as a liaison between NDC and Project Manager• Identification of unidentified material at various NDC sites using phpMyAdmin and MySQL Database Server loaded with NDC’s Materials Database• Preparing project reports (documenting unidentified materials, daily progress and writing resource deployment plans)• Preparation of project presentations for the NDC General Management Team• IT support (software & hardware) for Windows and Palm OS. Show less

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  GSK

  Apr 2005 - Feb 2020

  • Extensive technical writing experience in writing both procedural (Work Instructions, Standard Operation Procedures, Knowledge Base Help Articles, etc.) and project documentation (User and Business Requirements, Design Specifications, Test Cases, etc.)• Validation of quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures (Work Instructions, SOPs, Standards and Guidelines)• Reviewing & approving quality documentation (both procedural and project deliverables), ensuring compliance with regulatory requirements (GxP/GAMP) before publication. • Performing quality checks on documentation (spelling, grammar & readability) and providing feedback to document authors on required amendments• Maintaining and improving product quality, investigating customer complaints; collaborating with other members of management to develop new product and engineering designs and training methods• Maintaining training schedules for courses in IT Learning application and monitoring performance by gathering relevant data and producing statistical reports• Contribution to the development, maintenance and improvement of processes and procedures related to all aspects of Training Management, Document Management, and other areas of control. Show less

  • IT Quality, Risk & Compliance Specialist - Documentation

    Feb 2008 - Feb 2020

  • Technical Consultant

    Apr 2005 - Feb 2008
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  Amgen

  Feb 2020 - Jun 2021

  Specialist Technical Writer

  Worked for a pioneer in biologic therapies, which discovers, develops, and delivers innovative human therapeutics. As a member of the R&D Quality Compliance and Audit (QCA) group, I was responsible for supporting the development of controlled documentation for R&D processes.• Translation of subject matter expert and stakeholder discussion and/or process model flows into written controlled document procedures• Under tight timelines, lead and/or facilitate the writing, review, revision, and formatting/QC of controlled documents; adhering to format, content and style guidelines, considering usability and ensuring accuracy, consistency and quality according to templates and style guide• Serve as a process documentation subject matter expert and point of contact• Provision of regular status updates to manager/team lead/mentor and/or to business customers to achieve goals and meet deadlines• Develop, write, edit, and format materials such as Standard Operating Procedures, manuals, and related technical and business process documentation• Project manage/lead a cross-functional team of subject matter experts to drive R&D Quality processes including generation and management of MS Project timeline, identifying Quality strategy, oversight of process modelling and generation of process documentation. Show less

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  Kheiron Medical

  Jun 2021 - Jul 2022

  Technical Writer

  Responsible for production of technical documents for the following areas:* HIPAA / Privacy Compliance (Privacy/Compliance statements, FAQs, Knowledge bases)* Technical File / Design History File (e.g. User Manuals/IFUs, Risk Analysis/Assessment, etc.)* Operational processes (Work Instructions, SOPs, etc.)* Training (training manuals / programmes)

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  Haleon

  Aug 2022 - Dec 2024

  Quality, Risk & Compliance Manager

  Responsibilities:• Implementation of Governance & Compliance Framework, including establishing compliance processes and standards to be used within Digital & Tech organisation for the following areas:  Risk management  Audit readiness  Finance – Planning & analysis• Provision of consultancy and guidance in the following areas to tech colleagues to ensure compliance with regulatory requirements (GxP):  Document Management (Veeva Quality Docs eQMS)  Data Privacy (OneTrust)  Risk Management (Archer)  Audit Readiness  Third-party management  Asset & Configuration Management Show less

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  Acctu8

  Aug 2024 - now

  Senior Technical Writer

  Providing Technical Writing services to the Tech, Pharmaceutical and Medical Device industries.