Job Description

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\xe2\x80\x99s 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 visitA certificate will be given to successful trainees upon completion of the programme.Purpose:Perform QA oversight and manage quality compliance issues related to manufacturing and batch usage decision activities so as to maintain cGMP compliance in line with GSK and regulatory standards.Key Responsibilities:Quality Oversight:Interact with manufacturing personnel in day-to-day operations to ensure cGMP compliance.Support compliance in production area by routinely conducting QA checks such as checklist review, housekeeping checks, review of line clearance checks, verify compliance with SOPs,etc.Authorise campaign changeovers and participate in facility walkdown where required.Provide quality input and assistance in managing unplanned event investigations, CAPA implementation and change control monitoring.Ensure changes implemented on production areas are properly managed to prevent potential adverse impact to operations.Authorise QA processes e.g. Production Process Orders, Quality Tag Outs, Equipment releases, Room releases etc.Lead and coach a team of QA Executives to perform quality oversight activities. (For Lead Role Only)Review and approval of the following documentation as assigned:LSOPs / ChecklistsMaster Batch RecordsDeviations / EventsCAPAsChange controlsQuality tag outsReview and approval of executed Batch Records as assigned:Review of completed batch records and checklists (sterile buffers, intermediates and final adsorbed bulk).Monitor the quality of executed batch records and initiate actions as required.Batch Usage Decision:Perform quality review of buffers and intermediates for suitability to move batch status to "Restricted" where required for batch forward processing.Complete QA review of the sterile buffers and/or intermediates and take appropriate usage decisions.Move intermediate batches to restricted statusApprove checklist and logbook review summary section for batch release review summary formOther activities as assigned , for examples:Support site complaint investigationSupport periodic quality product reviewPerform internal auditsPerform risk assessment and/or gap analysis.Site KPI reporting etc. (For Lead Role Only)EHSComply with company requirement on EHSManagement and Planning (For Lead Role Only):Lead and supervise team of QA Executives to perform quality operationsPlan and organise team\'s day to day activitiesReport escalated quality issues to Line manager and key progressTraining and Development (For Lead Role Only):Plan and develop working knowledge and stakeholder management of the team of QA ExecutivesDecision Making:Proposals & RecommendationsIdentify potential compliance risks/ gaps and recommend improvementsIdentify improvement in quality processes and propose quality improvement strategies.Recommend direct report performance evaluation and training needs. (For Lead Role Only)Skills:Snr QA Executive 1 or 2ProfessionalUniversity degree in relevant Science or Engineering discipline.TechnicalGood understanding of GMP standard and regulatory requirements of pharmaceutical \'FldLlSt\xe2\x80\x9dUser experience with SAP preferredBasic understanding of regulatory inspection requirement.BusinessAbility to apply optimal quality assurance standards to promote business edge.Ability to communicate effectively within the site organisation and possess good people management skills.Ability to apply risk management skills adequatelyQA LeadProfessionalUniversity degree in relevant Science or Engineering discipline.TechnicalIn-depth understanding of cGMP regulatory and regulatory requirements of pharmaceutical ""ldUSt\xe2\x80\x9dUser experience with SAP preferredGood understanding of regulatory inspection requirement.Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes.BusinessAbility to apply optimal quality assurance standards to promote business edge.Ability to communicate effectively within the site organisation and possess good people management skills.Ability to apply risk management skills adequatelyCompetencies:Good Knowledge of FDA / EU/ ICH/ WHO as well as other relevant regulatory and technical guidelines.Possess analytical and quality performance mindsetDemonstrate professional and ethical integrityProficiency in English.Leadership qualities and supervisory skills. (For Lead Role Only)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 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