Site Name: Singapore - Tuas Posted Date: Oct 29 2024 Help us get ahead of disease together with our MSAT Product Stewardship Business Area Education required: University Degree in Engineering and/or Science related discipline, Advanced Science Degree in Data Analytics or similar field preferred Other requirements: Scientist or Engineer with working experience preferred Language requirement: Written and spoken fluency in English Application deadline: We will close this vacancy when we have enough applications, so please apply as soon as you can so your application can be considered. Looking to gain valuable real world work experience and help positively impact the health of billions of people? Apply for a GSK Traineeship today! The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals A certificate will be given to successful trainees upon completion of the programme. What will you do? Key responsibilities Continued Process Verification Participate to the CPV cycle of the designated product. Assist the Product Steward to manage CPV meetings Apply KPls to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues. Review and analysis process trending, identify changing quality trends and issues. With the support of Product Steward, suggest corrective actions to solve issue and improve the robustness and consistency of the manufacturing process. Responsible of the initiation and maintenance of TRA, PCS, DTP, CQA and QTTP of the designated product. Compile, interpret, and organize process and product data for periodic reviews, as well as audits / regulatory support. Closely interact with the MSAT Manufacturing Support Engineers and VS to monitor process performance through real-time performance data. Collect, record, and product report metrics. Establish visual tracking and other tools to enhance Audit readiness and trend analysis. Read and interpret statistical diagrams, drawings, and other schematics. Monitor processes for performance and problem indicators. Update the lifecycle of the process History file of the product. Aide users in both the Discoverant and PKM systems. Provide training as needed for both systems. Assess impact of changes on current validated process status and identify need for revalidation/revaluation activities Remain relevant in new business intelligent tools and become a SME in the field. Provide product expertise for the commercial production (i.e. expertise in the management of critical deviation). Work closely with MSAT Manufacturing Support and MSAT Process Science & Manufacturing Technology teams to identify and confirm critical process parameters needed for equipment and process validation. Audit preparation and manaqement - participate in L2 audit, corporate and regulatory inspections and front the inspector's questions as Subject Matter Expert. Project Manaqement - contribute to projects related to product life cycle changes or optimisation. Participate in product investigation task forces or working groups. What will you learn? MSAT Product Stewardship team provides technical assistance to commercial manufacturing team, including change assessment, process monitoring, troubleshooting and continuous improvement. Product Specialist plays a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. One meaningful and holistic approach to today's current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs. The primary focus of the MSAT Product Specialist role is to contribute to the lifecycle of products and processes manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products. The role of site MSAT Product Specialist is the care keeping and continuous improvement of the body of technical knowledge that the site has. It includes how we manufacture our products and transmitting that product & process knowledge into manufacturing instructions. What are we looking for? Technical 3 - 5 years' experience Understanding of databases and SQL Strong MS Office background (Excel, Word, Project, PowerPoint, Visio, etc.) Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues with the support of the Product Steward/Expert. Have very good written and verbal communication skills. Quantitative & qualitative analytical skills. Strong project management, planning, organizational and communication skills desired Business Strong understanding of Life Cycle Management disciplines, cross functional skills and processes. Experience with process monitoring and statistical analysis of data using statistical software (such as RedStar, Spotfire, JMP, MiniTab, Discoverant, etc.) Proven project management experience : projects with medium level of complexity. Proven experience with medium size, multiworkstream project management. Feel comfortable working in various cross functional teams. Competencies: Project management skills Technical knowledge Problem solving and analytical skills. Knowledge of GSK Vaccine processes and procedures Knowledge of vaccine environment; regulatory, NRA release, specificities of each vaccine family Knowledge of GMP environment, Sound knowledge of biopharmaceutical production processes. Sound knowledge of cGMP regulations and guidelines. What do we offer you? Understand and experience the GSK Culture Work with a diversified team of professionals Implement technical knowledge and skills that you have acquired at school Apply and develop soft skills such as interpersonal, communications and negotiation skills Transport to and from site to MRT stations in centralised locations all across Singapore (only for manufacturing sites) Let’s do this! You’ll find hints, tips and guidance on our recruitment process on our website – Learn more about the application process | GSK You can learn more about GSK and our careers here https://www.gsk.com/en-gb/careers/ Apply now! Need help with your application? Please email us at APAC.EarlyCareers@gsk.com and let us know how we can help you. 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. Important notice to Employment businesses/ Agencies GSK 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.