Quality Operations Specialist (temporary assignment)

Site Name: Italy - Siena Posted Date: Aug 2 2022 Why 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. 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. Job Title GVGH Quality Operation Specialist (temporary assignment - 12 months) In this role you will… Drive GVGH inspection readiness activities and be the spokesperson during the inspections for your subjects of expertise and areas of responsibility. Contribute to finalization of CAPA Plan and monitor the completion of each CAPA. Ensure application of GSK quality systems in GVGH operations Support Data Integrity reviews at the site Ensure quality compliance of GVGH and escalate major quality issues, compliance and/or data integrity gaps Contribute to creation and review of standards (e.g., SOPs, Work Instructions) for GVGH. Review protocols for laboratory equipment Work in a team of quality colleagues with the responsibility of Quality Audit readiness of third parties. Monitor the completion of the TP’s CAPA Plan Ensure application of cGMP during operations (such as deviations, CAPA, OOS, change control, documentation, validation) through the Quality oversight of TP Work closely with Qualified Person to support the product disposition. Work closely with CD&RA department to support the regulatory disposition Pro-actively identify and manage potential product quality and business risks Evaluate product impact and be responsible for quality decisions regarding products/activities in your areas Work across multiple value streams to drive continuous improvement and promote quality culture GSK Vaccines Institute for Global Health (GVGH) is a GSK-owned company, part of the GSK Global Health organization, committed to develop vaccines for major neglected diseases of impoverished communities. GSK Global Health organization is aimed to improve the health of people in the world’s poorest countries and to improve health security globally. Global Health approach is a central pillar of GSK’s Trust agenda and a key part of what makes us GSK. Why you?  Qualifications & Skills:  Degree in Scientific subject (CTF, Pharmacy, Biology or similar) At least 1-3 year experience in Quality Operation or QC environment Preferred qualification Knowledge and application of the principles of Quality Management Systems (QMS) Previous experience in GMP operational roles Demonstrated problem solving and decision-making capabilities Strong communication and influencing skills Ability to prioritize, manage workload, and escalate issues Ability to work well under high pressure and deadlines Gender diversity We are addressing gender equality at all levels within our organisation. With support from our Global Gender Council and our Women's Leadership Initiative (WLI) employee resource group, we are making great headway toward our aspiration of at least 45% female representation in senior roles by 2025. At the end of 2021, we reported strong growth in the diversity of our leadership and were on track overall to achieve our aspirations. 40% of senior roles were held by women (up from 38% in 2020); we are also proud that 50% of manager roles are held by women. We have been recognised in the FTSE Women Leaders report, The Times Top 50 employers for women, named one of India’s best companies for women, and our colleagues have been recognised by the Healthcare Businesswomen’s Association for their work to advance the impact and influence of women in healthcare. Ethnic diversity We remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. Our ethnicity commitments: - In the US: at least 30% ethnically diverse leaders in our VP and above roles by the end of 2025. - In the UK: at least 18% ethnically diverse leaders in our VP and above roles by the end of 2025. At the end of 2021, we reported strong growth in the diversity of our leadership and were on track to achieve our aspirations. We are proud that 27.1% of senior leaders in the US were ethnically diverse (up from 23.2% in 2020) and in the UK 12.9% of senior leaders were ethnically diverse (up from 11.1% in 2020). Disability GSK is committed to being inclusive for people with disabilities. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace where all our people can thrive. Since 2020, GSK has been an active member of the Valuable 500 pledge, a collection of 500 global companies all committed to placing disability inclusion on the leadership agenda. We are delivering on its objectives through our disability confidence plan. LGBT+ GSK aims to be an environment where everyone feels comfortable to be themselves and create their best work. 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