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Project Details

Pharma CSV Expert (Bilingual - Japanese & English)

A talent management company

 Mumbai / Navi Mumbai, Delhi / NCR, Kolkata, Chennai, Bangalore, Pune, Hyderabad

Posted on:  29/10/2020

Cinque Terre

Starts on:  5/11/2020

BROAD CATEGORY

Information Technology

SUB CATEGORY

Project/Program Management, Quality Assurance & Testing,

INDUSTRY

Pharmaceuticals

Company Details

A talent management company

Assignment Details

A talent management company is looking for a Pharma CSV consultant for their client, a joint Indian-Japanese IT venture with Japanese – English Bilingual skill.

Key Responsibilities :-
- Reviews requirements and functional solution and defines the SDLC/validation strategy
- Ensure that the project deliveries are in line with Customer SOP and quality framework
- Leads the relevant SDLC activities as defined in the validation plan. Ensures SDLC deliverables are accurate and appropriately approved
- Ensures the validation and testing activities are appropriately delivered
- Actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements and corporate standards.
- Must be aware of SDLC and deliverables- should be able to provide overall SDLC guidance and support.

Note : May require travel to Japan based on COVID 19 protocol.

Skills Required

- Japanese and english speaking consultant required
- Knowledge on GxP and Computer System Validation (CSV) , Customer SOP, aware of SDLC and deliverables, in the Japanese Market.
- Associated experience in pharmaceutical R&D domain would have an added advantage.
- Excellent communication skill and exposure on handling customers at onsite.
- Ability to work as a team player in a consulting environment.

Assignment Duration

12 month(s)

Capacity Required

Full Time

No. of Positions

2

Nature of Work

Remote

Profile Requirements

Experience: 10+ years

Qualification: Graduate

fleXpertise required

Japanese and English SpeakingComputer System Validation (CSV)Quality AssuranceSDLCTesting

ESTIMATED BUDGET

-

 

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