PurposeResponsible for sterility assurance programme and ensure compliance with company polices and current GMP expectations.Responsibilities1. QA OversightImplement sterility assurance programme on site.Review and approve gap/risk assessments relating to Sterility Assurance.Provide QA oversight to Sterility Assurance for site manufacturing processes and products manufactured by the site.Accountable for execution and maintenance of the Environmental Monitoring programmeProvide support to Value Stream in matters related to Sterility Assurance2. ComplianceEnsure all Sterility Assurance aspects of site manufacturing processes and products manufactured by the site are compliant with GSK standards and regulatory requirements.Provide input on aspects relating to Sterility Assurance for qualification and validation strategies.3. Management & PlanningProactive and timely engagement of internal or external stakeholders, as necessaryEngage the necessary stakeholders to formulate and drive projects relating to quality improvement initiatives.Apply good communication and project management skills.4. Training & DevelopmentDevelop and deliver training to relevant functions within site.Constantly update and improve training skills and delivery.Keep up to date with industrial best practices and current regulatory expectations.5. EHSComply with company EHS requirements.Skills, Knowledge & Experience1. Min degree in relevant science or engineering2. Min 5 – 7 years of experience in pharmaceutical industry especially related to aspects of sterility assurance and familiar with standard laboratory procedures and techniques.3. Experience in application of expertise and knowledge for the following domains:Bioburden & Endotoxin controlAseptic process simulationSterile hold-time (SHT) & Container closure integrity test (CCIT)Sterilisation methods, Vapourised hydrogen peroxide (VHP) decontaminationChangeover and Cleaning & disinfectionAseptic practice and aseptic manufacturing process understandingEnvironmental monitoring (EM) & Utilities4. Experience in application of cGMP regulatory requirements to quality assurance of vaccines and sterile medicinal product manufacturing5. Good understanding of regulatory inspection requirementsTo 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 – 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/ 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.
