Specialist QA Performance & Governance (6 months fixed-term contract/renewable)
Glaxosmithkline
Site Name: Belgium-Wavre Posted Date: Dec 2 2024 Come and join us to drive and support the Belgium QC in managing its quality performances and governances. As a member of the quality team, you will support the Monitoring Management process to be “inspection ready” and support the coordination of all audits and inspections. Key responsibilities: Quality Council: you prepare, facilitate, and follow up of Quality council action log You establish and continuously improve best practices for Quality council and Quality KPI performance reviews in line with requirements and which enables appropriate and impactful decision making and escalations. Inspection Readiness (IR): you facilitate efficient Inspection Readiness governance, establish and continuously improve best practices for IR meetings (Back-up LSPOC inspection). Monitoring Management Inspection management: you coordinate (L2/L3/L4) of audits and inspections to ensure smooth coordination, accurate description of requests and timely follow up of responses. QMS alignment: you ensure timely follow up of QMS gap assessments and remediation and proactively use the appropriate quality governance in case of risks. You lead quality performance improvement initiatives at local/site level by identifying challenges, good practices, by doing benchmarks Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Minimum a bachelor’s degree with a scientific orientation (biology, chemistry...) with the relevant experience Experience in a GMP environment Experience in audit and inspection Knowledge of cGMP and guidelines (FDA/EU/WHO) French speaker with a good level of written and spoken English Preferred Qualifications: If you have the following characteristics, it would be a plus: Master degree in science or quality management Strong Quality Mindset Ability to maintain a high level of integrity while balancing multiple priorities and responsibilities. Solution thinking oriented Strong communication skills Strong analytical skills and continuous improvement mindset Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines Sense of urgency, flexibility, and accountability. Strong analytical skills and continuous improvement mindset Demonstrated impact and influence #Li-GSK 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. 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. 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’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.
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