Job Description

Purpose

The (Senior) Quality Assurance Executive is responsible for providing quality input and oversight on the following areas during the new product introduction to Singapore Tuas site.

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

b. Introduction and qualification of material

c. Supplier and Service assessment of new materials and services to GSK

He/She is expected to partner with all project members to anticipate, prepare and meet project deliverables on all phases of the project.

As a Quality Assurance executive, 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 QA executive 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.

Key Responsibilities Area

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.

New Supplier and Service management of equipment and system supplier or service provider including supplier assessment.

New Material Introduction and Qualification

Review and approve new material and service introduction forms

Ensure new materials are introduced for material qualification, engineering runs and process validation timely as per schedule

New Supplier and Service management including supplier quality agreement, technical terms of supply, supplier assessment

Skills, Knowledge & Experience

• At least University basic degree in Science or Engineering disciplines
• At least 3 years experience in Pharmaceutical industry (For QA Executive)
• At least 5 years experience in Pharmaceutical industry (For Senior QA Executive)
• Understanding of cGMP and regulatory requirement within Pharmaceutical industry
• Good knowledge of safety and environmental regulation
• Hands-on experience in Pharmaceutical manufacturing (Preferred)
• Developing Project management skills or had hands-on experience in Project management (Preferred)

#Li-GSK

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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