Core Responsibilities:

• Responsible for implementation and validation of Computerized Systems for MNC customers.

• Ensure the system compliance with regulations and quality requirements of customers.Part of a multi-discipline team to deliver large projects to the required technical&industry standard.

Qualifications & Experience:

• Minimum of 5 years’ experience as a validation engineer working on pharmaceutical industry,Preferable in the life sciences sector

• University Engineering degree in Chemistry,Biotechnology, Computer Science,Automation&Any authorisations to work in other countries would be a distinct advantage

• Establish/optimize Computerized System Management and Quality Procedures for our clients.

• Ensure the GxP system following the regulation and drive for data integrity result.

• Ensure all GxP computerized systems (IT infrastructure,IT systems,lab automation equipment/ system and process automation systems)are properly validated prior to go-live.

• Prepare the validation core document such as validation plan,user requirement,design qualification,IQ/OQ/PQ protocol,CSV SOPs and working instructions.

• Perform risk control,change control and deviation management for Computerized Systems.

• Assist with commissioning&start-up phase of the projects through to formal acceptance of the system by the client on site.

• Operation and maintenance of Computerized Systems.Ensure all GxP computerized systems remain invalidated

• Status throughout the life cycle