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14 July 2020
Job ID: LP-841
IT Validation Engineer/วิศวกรตรวจสอบระบบสารสนเทศ

 

Key Duties & Responsibilities

  • To understand and follow compliance of IT regulations in security, quality and environmental prospective (i.e. Local/county laws, ISO 19001, ISO 14000 and etc)
  • Understand the software development life cycle methodologies and policies as laid out in the IT Standard Operating Procedure and policies
  • Direct in charge of Software and hardware quality system (i.e. ITCR, RA, URS, FDS, SDS, IQ, OQ, PQ, CSV) and other matter concerned with Information Technology department quality system.
  • Write documentation for new and current validation and/ or qualification procedures and technical reports.
  • Responsible for coordinate with QA for all validation cycles across RA, IQ, OQ, PQ, CSV and Change requests
  • Provides project updates to your supervisor on progresses of IT projects
  • Provides overall technical support to site manufacturing operations group in validation execution.
  • Support the development and continuous optimization Validation program-improving approaches to validation execution based upon risk management approach.
  • Establish and ensures the rigor of testing during all qualification/validation activities to be consistent with International and local applicable Authorities as well as Company requirements.
  • Provide support and technical expertise to solve problems occurring in routine processes.

 

 

Essential Experience/Skills

  • Bachalor’s degreein IT or any related fields
  • Good command in English
  • Good communication skill, Persuasion skill and Service minded
  •  Experience in medical device industry and work on Computer System Validation is advantage.
  •  Experience in Information Technology is an advantage.
  •  Experience in IT software development life cycle is an advantage.
  •  Computer literacy (MS Office: Word, Excel, and PowerPoint).
  •  Meticulous, able to do multitasking under given deadline.
  •  Positive thinking, able to self-starter, willing to learn new things, and flexible to changes.

 

 

 

 

 

 

Apply Now

Job Details:

Benefits:
  • Overtime pay
  • Performance bonus
  • Transportation allowance

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