งาน ใน ชลบุรี 605 ตำแหน่ง

กรุณาระบุอีเมล์ที่ถูกต้อง
บันทึกข้อมูลเรียบร้อยแล้ว, คุณจะได้รับข่าวเกี่ยวกับตำแหน่งงานใหม่ๆ ตามที่คุณลงรายละเอียดไว้ หรือใกล้เคียงกัน
24 มกราคม 2563
รหัสงาน: CH-12958
Senior Project Specialist, Information Technology (IT)

Performs tasks such as, but not limited to, the following:

  • Gathers Business Requirements and prepares FDA compliant documents based on those requirements.
  • Interacts with business community and customers to understand business process and define tools can be leveraged to leveraged to optimize the business process.
  • Ensures team members are provided with timely and accurate project information and status updates.
  • Ensure all systems are running in compliance with company and site policies
  • Plan, analyze and document tests for Manufacturing Execution Systems and other site systems in compliance with FDA regulations
  • Lead application validation
  • Manage adjustments or improvements to equipment and processes.

Knowledge/Skills/Competencies:

  • In-depth knowledge of development process.
  • Ability to Identify, gather, analyst and properly document system requirements.
  • Capable of ensuring that documents plus practices attain quality standards and applicable regulatory conformance.
  • Capable of implementing software validation engineering test plans, test cases/scripts.
  • Ability to propose solutions and collaborate in software validation procedures and processes.
  • Proven skills on implementation of computerized system validation projects with 3 years in developing computerized system validation plan and protocols.
  • Strong written and verbal communication skills with the ability to work through technical issues with customers both remotely and in person
  • In-depth knowledge of object oriented languages (Java, C++) and or good knowledge of scripting languages (Visual Basic, VB Script, JavaScript, HTML, Perl) and relational Databases and SQL
  • Ability to analyze and understand business requirements and to design solution specifications
  • This position requires a high energy level and a passion for excellence.
  • Very good command of written & spoken English.
  • Good command of written & spoken Spanish is an asset. 
  • Proven skills in project management.
  • Organization and time management.
  • Excellent technical knowledge in specialized domains.
  • Knowledge of development in an Windows Client/Server Platform or Unix Client/Server Platform

Physical Demands:

  • Duties of this position are performed in a normal office environment.
  • Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.
  • Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
  • Occasional overnight travel is required.

Typical Experience:

  • 5 years of IT computer validation with experience in medical device manufacturing operation
  • Experience in a regulated environment with in depth knowledge and experience with cGMPs/GLPs/GAMP regulations related to medical device manufacturing systems, CFR Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971.

Typical Education:

  • Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering.
  • Training in validation methodologies, technologies and process control computer systems.

รายละเอียดงาน:
  • ประเภทการจ้าง:
    งานเต็มเวลา, งานประจำ
  • ประเภทธุรกิจ:
    ธุรกิจอุปกรณ์ไฟฟ้า ธุรกิจอุปกรณ์อิเล็กทรอนิกส์
  • สถานที่ทำงาน:
    ชลบุรี, ประเทศไทย
  • เงินเดือน:
    สามารถต่อรองได้

RLC Recruitment Co., Ltd.
https://rlc-asia.com/
RLC was recently established to address the needs of the growing number of companies looking for a customized and personal approach to recruitment. The experienced Management Team of RLC bring with them collectively many years of local and regional recruitment know-how gained in the local Thailand market and in SEA. RLC offers recruitment services in the following sectors; Heavy Industry, Light Industry, Life Sciences and Services. The core of the business caters to mid range level professionals to senior and executive management appointments.

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