Site Name: Singapore - Tuas Posted Date: Apr 9 2024 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. Purpose: To be primarily responsible for the sterility assurance program and ensure compliance with company polices and current GMP expectations. Key Responsibilities: QA Oversight Implement sterility assurance program 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 the execution and maintenance of the Environmental Monitoring program Provide support to Value Stream in matters related to Sterility Assurance Compliance Ensure that 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 Management & Planning Proactive and timely engagement of internal or external stakeholders, as necessary Engage the necessary stakeholders to formulate and drive projects relating to quality improvement intiatives Apply good communication and project management skills Training & Development Develop and deliver training to relevant functions within site Constantly update and improve training skills and delivery Keep up to date with industry best practices and current regulatory expectations EHS Comply with company EHS requirements Deputization For Senior QA SA Executive, deputize N+1 responsibilities as required Decision Making: Proposals & Recommendations Using a risk-based approach, define the scientific approach, rationale and requirements as part of identification and assessment of Sterility Assurance risks arising from projects relating to facilities, processes, plant and equipment Identify and solve problems related to Sterility Assurance, based on available information, using a scientific approach Provide inputs to supporting and/or performing gap/risk assessments against VSOPs and GQMPs (where applicable) relating to Sterility Assurance, and recommend solutions for closure of such gaps Propose and drive quality improvement initiatives on site Skills: Professional University degree in relevant Science (microbiology preferred) or Engineering discipline. Technical Experience in application of expertise and knowledge for the following domains: Bioburden & endotoxin control Media Simulation SHT &CCIT Sterilisation Methods VHP Changeover Cleaning Disinfection Aseptic Practice EM & Utilities Working or good (senior role) knowledge/ experience in application of cGMP regulatory requirements to quality assurance of vaccine and sterile medicinal product manufacturing Good understanding of regulatory inspection requirements Business Builds competencies within the site by developing and delivering technical training packages Interface with relevant internal stakeholders on site to cascade critical/important information relating to regulatory compliance/expectations, the how and why, and industry best practices Provide inputs to support the evaluation of CAPA globalisations / Quality Alerts relating to Sterility Assurance, and also to support the internal stakeholders in formulating actions rising from such evaluations Provide inputs in supporting site inspections and supplier audits for matters relating to Sterility Assurance Apply risk management skills effectively Ability to apply optimal quality assurance standards to promote a business edge Competencies: Bioburden & endotoxin control Media Simulation SHT &CCIT Sterilisation Methods VHP Changeover Cleaning Disinfection Aseptic Practice EM & Utilities Working or good (senior roles) knowledge of FDA/EU/ICH/WHO as well as other relevant regulatory and technical guidelines Aseptic manufacturing process understanding Quality performance mindset Good analytical and problem solving skills Ability to take difficult and risk-based decisions based on available information Demonstrated professional and ethical integrity Fluency and proficiency in the English language Good writing skills Ability to operate independently Where will I be based? You will be based at one of our manufacturing site in Singapore near Tuas. How can I apply? Applications are now open. Click on the button above to apply. We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis! At GSK we value diversity and treat all candidates equally. We strive to make our recruitment process free of bias of any kind and aim to create an inclusive workplace at GSK. If you require any assistance, either to attend an interview or during the course of the recruitment process, please let us know. Why Us? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. 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. 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