Job Description

Purpose:The (Senior) Quality Assurance Executive is responsible for providing quality oversight and manage quality compliance issues related to manufacturing, quality control and batch usage decision activities for project implementation in Singapore Tuas site to maintain cGMP compliance in line with defined quality requirements and regulatory standards.He / she is expected to establish effective working relationship with project team members ranging from local to global partners to meet project deliverables.Key Responsibilities:

• Accountable for quality inputs and ensure compliance to regulatory requirement, QMS (Quality Management System), VSOPs, local site procedure and / or defined Project Quality Management System throughout the project lifecycle.

• Develop and align strategy and deliverables with project stakeholders to meet project milestones such as but not limited to QC method and reagent qualification strategy and deliverables.

• Identify and mitigate potential risks (e.g. quality issues) with project team during execution and avoid / minimise disruption to project milestones and routine operations.

• Ensure project related changes implemented on production and QC areas are properly managed and documented to prevent adverse impact to operations. Authorise QA processes.

• Provide quality input in managing unplanned event investigations, CAPA (Corrective and Preventive Actions) implementation and change control monitoring for project related operations.

• Challenge status quo to simplify and optimise way of working

Skills, Knowledge & Experience:

• Minimum Basic university degree in Science or Engineering disciplines
• Minimum 5 years\xe2\x80\x99 experience in pharmaceutical industry
• 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)
• Knowledge of FDA / EU / ICH / WHO / Chinese FDA as well as other relevant regulatory and technical guidelines
• Vaccines manufacturing process understanding
• Analytical and Quality performance mindset
• Demonstrate professional and ethical integrity.
• Strong communication and writing skills (ie. Fluent in English language)
• Able to develop strong cross functional relationship and partnership with stakeholders to deliver project milestones.
• Flexible, agile, and adaptive to changes
• Ability to work both as an individual and as team player

Why GSK?Uniting science, technology and talent to get ahead of disease together.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. 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\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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

GlaxoSmithKline