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IT CSV Specialist / System validation (Bilingual) 【IT project/Emerge】 契約社員 (掛川市勤務)

Job Title: IT CSV Specialist / System validation (Bilingual) 【IT project/Emerge】 契約社員 (掛川市勤務)
Contract Type: Contract
Location: Japan
Industry:
IT
Reference: 2272
Contact Name: Takashi Seta
Job Published: February 13, 2019 18:53

Job Description

Description

This is a global role out project and we have already executed in couple of countries.
Japan transition will start in Feb.
This position is very important for the project.

Job Description:
Planning, Implementation, Testing, Deployment and Maintaining.

- Life science pharma domain
- Computerized system validation as per GAMP5, EU Annex 11 21 CFR Part 11 regulatory standards.
- Performing Data Integrity Audits, Verifying integrity of GxP data generated recorded by a manufacturer ensuring data is accurate, complete reliable
- Performing end to end validation deliverables like VMP, URS, FRS, DS, IQ, OQ, PQ and VSR of GxP software as per the regulatory standards
- Development review of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment
- Validation documentation like Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQOQPQ Test Protocols
- FAT and SAT activities and should be able to guide team for execution of test cases, handling deviations defects occurred during testing
- Spplying FDA regulations to the aspects of the Computer and Lab Systems
- Create, revise, and update control system SOPs in support of protocols, computer system changes, and departmental operations
- Perform GAP analysis, Risk Assessment using FMEA model, implement Quality Risk Management Systems to define validation strategy, prepare risk scenario and RPN evaluation

General working hours and break time, holidays
Duration: 8-12 months.
Details will be disclosed at the interview

Requirements

Requirements:
- 5+ years of experience in life science pharma domain
- Well versed with computerized system validation as per GAMP5, EU Annex 11 21 CFR Part 11 regulatory standards.
- Expertise in performing Data Integrity Audits, Verifying integrity of GxP data generated recorded by a manufacturer ensuring data is accurate, complete reliable

- Expertise in performing end to end validation deliverables like VMP, URS, FRS, DS, IQ, OQ, PQ and VSR of GxP software as per the regulatory standards
- Experience in development review of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment
- Handson experience in validation documentation like Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQOQPQ Test Protocols
- Handson experience in FAT and SAT activities and should be able to guide team for execution of test cases, handling deviations defects occurred during testing
- Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems
- Hands experience to create, revise, and update control system SOPs in support of protocols, computer system changes, and departmental operations

- Perform GAP analysis, Risk Assessment using FMEA model, implement Quality Risk Management Systems to define validation strategy, prepare risk scenario and RPN evaluation

Job details

Language requirement
Japanese (Business advanced), English (Business advanced)