Senior Computer System Validation EngineerID:62950

30,000 THB ~ 50,000 THBLamphunOver 3 months ago

Overview

  • Salary

    30,000 THB ~ 50,000 THB

  • Industry

    Manufacturing(Other)

  • Job Description

    - Involve with the ERP projects to support and translating the business requirements into validation & compliance requirements.
    - Plan, organize, execute & document IT & QA activities with IT team for ERP system projects & regulated systems.
    - Handle change control requests as per IT and Business Standard operating procedure to ensure that sufficient documentation are in place.
    - Strong experience in managing testing throughout the SDLC for MES, establishing Validation Plans (VP) and Testing Strategy.
    - Hands-on experience in writing test cases, test data preparation and test execution. Expertise in writing test scenarios using design
    specification documents.
    - Good knowledge in writing testing/qualification protocols.
    - Prepare computerized systems documents, VP/VMP, URS, FDS/FRS, SDS/TDS/DDS, XQP, TRM/RTM, RA, IQ, OQ, PQ, XQR, WIs, SOPs, Forms, Traceability Matrix and Validation Summary Reports.
    - Coordinate with QA and business operations for validation activities, perform installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) activities.
    - Ensure compliance of IT regulations in security, quality and environmental prospective (e.g., ISO 19001, I SO14000, etc.) as
    well as global IT policies and procedures.
    - Support Global CSV Lead on quality and compliance of ERP systems.

Qualifications

  • Requirement

    - Male/Female, age 27 years old up.
    - Bachelor’s in computer science or Information Technology or Bachelor of Science with IT background.
    - Minimum of 3-5 years of experience in Computer Systems Validation processes.
    - Preferably with experience in software validation from medical device industry or pharmaceutical industry.
    - Good understanding of system development life cycle.
    - Exposure to FDA compliance CFR part 11 and EMA Annex 11.
    - Experience in Manufacturing systems.
    - Good Project Management skills to complete assigned CSV projects individually.
    - Good communication skills.
    - Ability to express thoughts and complex IT solution clearly and in a simplified manner to be understood by non-IT users.
    - Team player. The ability to work as a team with other IT people across the globe is essential.
    - Excellent organization, prioritization & problem-solving skills.
    - Good at collaborate with cross functional teams across the globe is essential.
    - Good at collaborate with cross functional teams.

  • English Level

    Level 3 - Business Level

  • Other Language

    Thai, English

Additional Information