QA Executive

Site Name: Singapore - Tuas Posted Date: Dec 15 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 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 defined quality requirements and regulatory standards. Key Responsibilities Area 1. 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. 2. Review and approval of the following documentation as assigned: LSOPs / Checklists  Master Batch Records Deviations / Events CAPAs Quality tag outs 3.Review and approval of executed Batch Records as assigned: Review of completed batch records and checklists (sterile buffers, intermediates or final adsorbed bulk). Monitor the quality of executed batch records and initiate actions as required. 4. Batch Usage Decision: Complete QA review of the sterile buffers and/or intermediates and take appropriate usage decisions. 5.Other activities as assigned, for example: Support site complaint investigation Support periodic quality product review Perform self-inspections Perform risk assessment and/or gap analysis Perform periodic quality review i.e. buffer, QTO, ATR, alarms Support corporate or regulatory inspections 6. Act as a Subject Matter Expert for the topic identified, including: Own related SOP and Checklists and train personnel Maintain the expertise up-to-date Perform gap assessment / implementation assessment against corporate or vaccines reference documents Support self-inspections and internal audits Front during corporate or regulatory inspections 7. EHS Comply with company requirement on EHS Skills, Knowledge & Experience University degree in relevant Science or Engineering discipline At least 1 year of experience in pharmaceutical industry preferred. Basic understanding of GMP standard and regulatory requirements of pharmaceutical industry User experience with SAP preferred Good knowledge of FDA / EU / ICH / WHO as well as other relevant regulatory and technical guidelines. Possess analytical and problem solving skills. Demonstrate professional, ethical integrity and quality mindset. Proficiency in English and good technical writing skill. 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.