Job Description

Site Name: Singapore - Tuas
Posted Date: Apr 4 2023

Purpose

Tuas is setting up a project team to implement Manufacturing Execution System (MES), to enable the use of electronic batch records (EBR) for the prodcution processes. The QA Validation Specialist is proficient in Computer Systems Validation and developing validation strategy for implementing a global computer system on site. He / she is responsible for ensuring that MES validation is in compliance with company procedures, regulatory requirements and cGMP expectations.

Key Responsibilities Area

• Define the validation strategy for site implementation by adopting existing validation strategy for MES implementation from Global MES Team and include local validation scope if any.
• Advise, review and approve the validation deliverables, ensuring compliance with company procedures, regulatory requirements and cGMP expectations and meeting project schedule. Provide solutions to achieve validation requirements
• Assess impact to validation for changes that occur during the project, and define appropriate validation requirements and approach to meet these requirements.
• Identify potential compliance risk and gaps, and recommend improvements
• Propose recommendations for issues resolution that requires support, guidance or steering with Project Lead and / or Project Sponsor.

Skills, Knowledge & Experience

• Bachelor\xe2\x80\x99s degree in science of engineering
• 4 to 6 years\' experience in Pharmaceutical Manufacturing
• Mandatory strong experience in computerized systems validation
• Prior experience with MES usage or MES implementation project is an added advantage.
• Excellent communication skills both verbal and written.
• Preferably with Lead experience

#Li-GSK GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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