Validation coordinator

Site Name: Belgium-Wavre Posted Date: Dec 3 2022 Job Purpose GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to produce Clinical lots, robust product, process development and launch of novel vaccines. The Validation coordinator is accountable to coordinate validation activities in collaboration with Quality Assurance, Producer, Technical Service, Quality Control and Expert. Key Responsibilities Responsible for the coordination of the validation of one major vaccines projects in Drug Substance or several major vaccines projects in Drug Product in TRD GMP Manufacturing department. Participate in project of both DP and DS area. Responsible for ensuring the coordination (planning, weekly validation committee participation) of one investment project (new manufacturing facility) from the Basic design step to the license file approval. Takes actions to monitor and control costs within budgetary constraints Ensure correct and state of the art Validation approaches, be responsible to establish the Validation Plan and for all GMP decisions taken during the Validation of the project starting with the Design Qualification step and ending with the establishment of the Validation Summary report. Including : Responsible for writing, reviewing and approving validation documents (Risk Assessment, PQ Protocol, PQ Report,…) Responsible for coordination of PQ execution activities. Responsible for the implementation of the validation policies for the processes & equipment (Validation life-cyle process, Qualifications, Process Validation and computer-related systems validation). Responsible for ensuring, during the design and validation steps (until the end of lots production) for the vaccines or facility project: writing, an independent review and first approval of validation documentation Participation to perform the writing of the facility submission files for the facility projects Responsible for participating, for validation sections, in external authorities’ inspections (EMEA, FDA, WHO…). Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards. Responsible for assuring inspection readiness – regarding Validation – by Corporate GSK functions and RA authorities (FDA, EMEA, Canada) Responsible for coaching new comers in the validation team and trainees from GSK Bio sites in the GMP and validation context in order to develop skills and competencies to implement Best Practices Be expert in at least one validation subject and represent TRD in this area. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline At least 5 years’ experience in aseptic processing or vaccine production including knowledge of the scale up principles, quality control tests, production technologies and Good Manufacturing Practices. Expertise in PQ validation and GMP, strong knowledge in a matrix organization and project management. Strong communication, organizational and influencing skills to work transversally. Be able to take decisions using incomplete information. Be able to identify solutions to non-standards tasks; thinking out of the box; stay critical. Bring motivation and enthusiasm to engage projects’ team members. Fluent in French and in English 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 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. Find out more: Annual Report 2021 We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D. *Li-GSK *RDVaccines 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. 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