Site Name: Singapore - Tuas
Posted Date: Sep 4 2024

Purpose:

The Senior QA Validation is responsible for providing quality input and oversight on the following areas during the new product introduction to Singapore Tuas site.

• Design, construction, commissioning and qualification of new facility, equipment technology and system
  

You are expected to partner with all project members to anticipate, prepare and meet project deliverables on all phases of the project.

As a Senior QA Validation, he/ she represents the project team and point of contact on project quality matters related to equipment and material related activities. He/ she establishes effective working relationship with quality functions of supplier for facility, equipment, systems and material commissioning and qualification, global QA in GSK Vaccines and local site QA in Tuas.
The Senior QA Validation ensures that all commissioning and qualification activities under the project scope is designed in compliance with all applicable GSK Quality policies, regulatory requirement, and GMP practices/ procedures in place and in use within GSK Tuas.

Responsibilities:

General Project Quality Management:

• Ensure quality-by-design in all aspects and stages of the project is in alignment with the defined Project Quality System and Quality Plan
  
• Accountable for quality inputs and ensure compliance to regulatory requirement, QMS, VSOPs and local procedures throughout the project lifecycle with regards to qualification and validation
  
• Deploys the appropriate project documentation through the project lifecycle.
  
• Identify and anticipate potential quality issue during the course of the project execution and avoid / minimize disruption to operations and compliance of GMPs.
  
• Execute quality compliance gap assessment exercises at appropriate stage of the project lifecycle.
  
• Ensure proper ties-in strategies and solutions between new facility and existing GMP areas to avoid / minimize disruptions to routine GMP operations.
  

Facility, Equipment, System Design, Development and Qualification:

• Define commissioning and validation approach and ensure deliverables are met per commissioning and validation plan to achieve validation status of the facility, equipment, technology and system.
  
• As an oversight of the validation activities, ensure all commissioning and validation requirement are met.
  
• Ensure timely completion of validation activities as per project schedule.
  

Knowledge, Skills and Experience:

We are looking for professionals with these required skills to achieve our goals:

• Minimum degree in Science or Engineering disciplines.
  
• Minimum 5 years of experience in pharmaceutical industry
  
• Minimum 3 years Cleaning, Environmental Monitoring, Utilities Performance Qualification and Process Validation Experience
  
• Must have equipment and facility qualification experience.
  
• Knowledge in Production and QC Operation experience
  
• Knowledge in Cross contamination
  
• Understanding of c GMP and regulatory requirement within pharmaceutical industry.
  
• Background in Computerized systems
  
• Background in equipment, facility validation experience
  
• Good knowledge of safety and environmental regulation
  
• Has experience leading a project
  
• Hands-on experience in pharmaceutical manufacturing (Preferred)
  
• Developing Project management skills or had hands-on experience in Project management (Preferred)
  

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
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