Senior Specialist QA Incoming Material – Pack

Site Name: Belgium-Wavre Posted Date: Dec 5 2022 Senior Specialist QA Incoming Material (IM) - Pack Job purpose: Drive quality of suppliers and Incoming materials (IM) for GSK Vaccines Belgium site, with a specific focus on Pack materials Manage and ensure appropriate QA oversight of qualification and life-cycle activities of incoming materials - including initial qualification, investigations, CAPAs, supplier notifications, internal changes and complaints - in order to ensure a robust supply pipeline. Drive quality decisions on IM. Master Quality Escalation processes (including LIC secretary role). Understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials. Ensure implementation of QA IM quality improvement plans and maintain inspection readiness status. In this role you will… Understand and manage autonomously quality aspect of suppliers and materials qualifications in partnerships with key stakeholders (SPU IM stakeholders/ procurement/ QSIM/ QC/ Engineering/ provisioning/ MSAT). Support the drive on supplier investigations, improvement projects and relationship management. Perform Quality Oversight on most investigations (deviations and market complaints) in partnership with SPU IM Ops, QSIM, MSAT, QC, Belgium manufacturing facilities and suppliers to identify and follow up root causes and CAPA’s, as well as IM product impact assessment and root cause. Perform Quality Oversight on local supplier change notifications to ensure appropriate review and implementation. Escalate suppliers/quality issues to stakeholders through appropriated escalation processes. Manage associated actions (QEF, BPDR, …). Act as key member to the Technical Lifecycle team meetings. Promote supplier Quality Improvement projects and contribute to Supplier Quality Monitoring. Support supplier quality system audits on request and assess supplier capability to meet product requirement specifications. Manage current regulatory requirements, as well as internal, environment related to incoming materials. Promote a customer focus spirit. Cultivating a network of collaborative internal relationship and supplier network. Promote continuous improvement mindset and initiatives. Manage trainees and externals in their specific job. Serve as back-up of the team head to manage critical initiatives and critical issues. Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade. Why you? Qualifications & Skills: BS, Ir, Pharmacist, PhD Degree in a relevant scientific, quality or technical discipline and relevant experience in (bio)pharmaceutical manufacturing and/or quality operations. A minimum of 5 years’ experience in Quality Operations Good understanding of packaging processes Knowledge of regulatory and quality system requirements and ability to explain, influence and negotiate with supplier organizations to comply with standards. Fluency in English and French Preferred Qualifications & Skills: Experience with Microsoft Office applications and have the ability to learn new software applications such as SAP. Demonstrated ability in project management experience. Experience in planning and executing pharmaceutical supplier audits to identify, manage, correct and reduce significant risks / non-compliances. Good verbal and written communications skills to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place. Ability to function efficiently in a matrix organization in order to ensure effective use of resource and communication of issues to all impacted sites / functions. Experience and management of negotiations and ability to influence stakeholders to ensure implementation of appropriate regulatory requirements and quality standards. Why 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 organization 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. Find out more: Annual Report 2021 If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. 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