Senior Computer System Validation EngineerID:62950
30,000 THB ~ 50,000 THBLamphunOver 3 months agoOverview
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
Benefit
- Provident Fund
- Medical insurance
- OT
- Bonus
- Other allowanceWorking Hour
08.00 ~ 17.00
Holiday
Working on Sat twice per month
Job Function