Job Description

Purpose:To provide technical support to the project team for Quality Control (QC) related activities for the new projects introduced in GSK Tuas. The QC Specialist ensures that all aspects of analytical equipment qualification is successfully completed. He/ She will also support the local QC unit to be ready to transit into lifecycle management.Key Responsibilities:Project Management:

• Leads new equipment / technology introduction.
• Provides expertise and consultation to project team on technical QC matters to ensure compliance to applicable corporate, regulatory and external agency regulations.
• Ensure timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.
• Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
• Work closely with global/local QC stakeholders to develop and endorse the following:

• Cost management (eg. facility, analytical equipment)
• Training plan
• Laboratory expansion plan
• Collaborates closely with global and Belgium QC departments on test method innovation/ evaluation to support the project team in facility design / laboratory expansion, specifically for QC operations.
• Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).
• Identifies risks and challenges on QC matters for escalation and resolution.
• Ensure spendings are within project target budget

QC operations:

• Anticipate, plan and execute the transition from a project mode to routine mode in terms of QC operations.
• Knowledge management on knowledge retention and effective training to ensure equipment knowledge is effectively transferred to routine testing team.
• Identifies the need for and scope of subsequent local QC representatives and supports their onboarding.
• Support local QC management in areas of knowledge management and training for the new equipment.

Safety:

• Respects all safety and security polices, laboratory policies and practices on site and ensures policies and SEHSS are deployed and respected.
• Ensure all related work activities are carried in according to site EHS polices and procedure.
• Ensure that contractors comply with the site/ safety requirements, e.g. LOTO, permits.
• Establish new safety and security policies and practices.

Skills, Knowledge & Experience:

• Minimum Diploma in a relevant science discipline
• At least 2 years of relevant working experience within the biopharma industry
• Must have laboratory experience in pharmaceutical industry
• Laboratory equipment qualification and new technology introduction
• Computer system validation for analytical equipment
• Knowledge of cGLP & cGMP
• Knowledge of USP and EP requirements for anaylical equipment qualification

To learn more about Singapore GSK and our people, please click on this link:#Li-GSKWhy 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