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:
- Min degree in chemistry, science or engineering
- Min 2 years of experience in pharmaceutical industry
- Min 2 years of experience in commissioning & system validation
- Understanding of cGMP and regulatory requirement within pharmaceutical industry.
- Background in Computerized systems
- Background in equipment, facility validation experience
- 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)
- Experience in start-up projects.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s 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 – 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.
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