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Pharma CSV Expert (Bilingual - Japanese & English)

  • Full Time
  •  Remote - Mumbai / Navi Mumbai
  • 12 months
  • Project posted on: 29/10/2020

Pharma CSV Expert (Bilingual - Japanese & English)

  • Information Technology
  • Project/Program Management
  • Quality Assurance & Testing

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

Full Time

12 months

 29/10/2020

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.

About the Client

A talent management company

Industry

Pharmaceuticals

Minimum Experience:

10+ years

Additional Skills:

  • Quality Assurance
  • Japanese and English Speaking
  • Testing
  • SDLC
  • Computer System Validation (CSV)

No of open positions:

2

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