Senior Consultant

Senior Consultant

Job Title: Senior Consultant
Contract Type: Contract
Location: Malaysia
Reference: JOB_001600[670]
Contact Name: SBO (+65 65603224)
Contact Email:
Job Published: July 10, 2020 17:12

Job Description

We are looking for a Senior Consultant, who is/are able to fulfill the following requirements:

Duration: 12 Months

- With at least 10 year of relevant experience
- GxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledge

Roles and Responsibilities:
- Deliver ISRM services to the client they are part of to help ensure that information and IT systems are adequately protected against unauthorized disclosure (confidentiality), unauthorized alteration (integrity), unavailability (availability) and non-compliance 
- To ensure identified project methodology is followed and deliverables are produced in line with validation approach- Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed
- Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Computerized System Validation (CSV) concept
- Preparation for compliance audit, attending meetings and assisting in addressing any issues. Also Supporting Project Manager in risk management activities
- Able to manage direct relations with stakeholders and project team members.
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics.

Please send your application to with (JOB_001600) in Subject line and highlighting:
- Your relevant experience
- Current/expected salary 
- Availability information 
- A latest MS-WORD Resume