Urgently looking for IT QA Bilingual(Japanese)

5 - 10 Years
Bengaluru, Mumbai, Chennai, Hyderabad, Pune

Job Description


We are hiring IT CSV Specialist with Japanese(N3) and English fluency.

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

Salary: Not Disclosed by Recruiter

Industry:IT-Software / Software Services

Functional Area:IT Software - Application Programming, Maintenance

Role Category:Programming & Design

Role:Testing Engineer

Employment Type:Permanent Job, Full Time


Desired Candidate Profile

Please refer to the Job description above


Doctorate:Doctorate Not Required

Company Profile

FCS Software Solutions Limited

FCS is a leading provider of IT services. In the past one decade of its existence, FCS has carved out a niche for itself in core IT areas like E-learning, Digital content services, Resource staffing, BPO and Product engineering services. As a business innovator, FCS helps clients achieve extraordinary results from their customer relationships, business operations, and technology. Clients choose FCS for the impact we achieve, our commitment to their success, and the straightforward and collaborative way we work with them. Our customers list include Medidata, Canon, Merck, Samsung, TCS, Axalta Coating Systems and many more Fortune 500 companies. In annual (2011) RD Scorecard of the companies from across the world, the European Unions executive body European Commission (EC) has ranked FCS Software Solutions 18th among Indian firms. We have state-of-the art facilities based at Noida and Chandigarh running 24x7. Our continuous growth has been made possible by the result of livewire, energetic and focused IT workforce of more than 900 highly competent professionals who have worked extensively in the areas of application development and support, e-learning solutions, Business, Infrastructure Management, and BPO. For more details, click on www.fcsltd.com.
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Recruiter Name:Shikha

Contact Company:FCS Software Solutions Limited