QA Executive

Site Name: Singapore - Tuas Posted Date: Dec 16 2022 To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore Purpose To assist Quality Lead (Systems) and Manager (Compliance and Systems) in the management and administration of quality systems in line with GSK standards and cGMP regulatory requirements. Quality systems include document management, training compliance, archival, etc. Why you? Key Responsibilities Area Document Management System Be the administrator of the Document Management System, as assigned Process owner for Document Management System on site, including manual fallback system, as assigned Perform review and gap analysis of QMS/VSOP documents against the in place and in use compliance to local procedures Implement and sustain key initiatives to improve system / workflow Initiate and review deviations / change controls / CAPAs associated with documentation system. Ensure that all deviations / change controls are closed or assessed for impact on documentation system Generate and assess relevant metrics for documentation Provide QA consultation and troubleshoot on documentation related issues. Review / Author of SOPs related to Documentation Management System Perform annual system review for effectiveness and implement actions accordingly Be the backup for issuing batch records in a timely manner to meet production requirements, as required. Be the backup of performing compliance and PDF checks for documents to ensure that documentation is complete and accurate. Site Document Archival System Process Owner for document archival system on site. Manage Archive storage location on-site. Maintain QA oversight of documents archived on-site and off-site. Provide QA consultation and troubleshoot on document archival related issues. Work with document controllers to maintain a robust site document archival system. Initiate and review deviations / change controls / CAPAs associated with document archival system. Ensure that all deviations / change controls are closed or assessed for impact on archival system Review / Author of SOPs related to document archival Perform annual system review for effectiveness and implement actions accordingly Site GMP training system Process owner for GMP training system on site, as assigned Maintain QA oversight of the processes for Training and perform governance checks on executed Training Change Request (TCR). Support management of electronic tracking system (PIER, myLearning). Manage site training metrics reporting. Provide QA consultation on GMP training related issues. Work with Learning Team to maintain a robust site GMP training system Initiate and review deviations / change controls / CAPAs associated with GMP training system. Ensure that all deviations / change controls are closed or assessed for impact on training system Review / Author of SOPs related to GMP training. Perform review and gap analysis of QMS/VSOP documents against the in place and in use compliance to local procedures. Perform annual system review for effectiveness and implement actions accordingly Be the backup to support review of Training Change Request (TCR) as training technical reviewer. Support the management of the SQC meetings, ensuring decisions and action logs are captured through the meeting minutes, and followed through during the SQC meetings Propose organizational methods and tools to improve effectiveness of system activities Propose initiatives to improve system usage compliance Deviations investigations and assessments Skills, Knowledge & Experience: At least University basic degree in a Science or Engineering discipline QA Executive: Experience in pharmaceutical industry in GMP regulated areas is preferred. Senior QA Executive: At least 3-5 years of experience in pharmaceutical industry in GMP regulated areas. User experience with SAP will be preferred. Good knowledge of quality management systems QA Executive: Good knowledge of GMP requirements and regulatory expectations Senior QA Executive: An extensive understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing. Ability in handling and organizing multiple workflows Ability to understand the functionalities of systems and link with usage capabilities Why GSK? Uniting science, talent, and technology to get ahead of disease together Vaccines help protect people from infectious diseases at every stage of life and our portfolio of marketed vaccines is the broadest in the industry. Our vaccines facility at Tuas is a key manufacturing site within our global network supplying the active ingredients used to make multiple pediatric vaccines. Tuas site was officially opened in 2009. To date, the site has played a key role in producing more than 800 million vaccines for pneumococcal diseases. Tuas has a workforce of more than 300 employees. We are expanding operations at our Tuas site adding new exciting products to our production capabilities and becoming an even more significant part of GSK’s worldwide vaccines supply chain. We are looking for motivated individuals to join us in uniting science, technology and talent to get ahead of disease together.
Li-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.