Site Name: Belgium-Rixensart
Posted Date: Oct
About the role
Contribute to management of Validations/Qualifications/Commissioning for investment projects and laboratory equipment for VxCL&AP.
· Represent users in all validation /commissioning steps for CAPEX projects.
· Support the setup of the validation /commissioning process and be the key contact point between the various teams.
· Ensure the application of standards, procedures and norms according to R&D activities.
· Ensure the application of the validation strategy of the department by partaking to workshops, meetings and by enabling the implementation of requirements via on-site supervision.
· Asset management representative for validation activities (IQ-OQ-PQ).
· Manage validation documentation linked to infrastructure equipment management and electronic requests for laboratory equipment within R&D in GxP and non-GxP environments (new equipment, move, restart equipment, stock, destruction)
About the responsibilities
As validation representative for R&D projects and RMTs, you are responsible to :
* Write and review URBs, TCDs, validation plans, protocols/reports, IQ/OQ/PQ.
* Ensure correction and approbation of IQ/OQ protocols.
* Synthesis report edition within validation plan requirements.
* Manage CAPA and deviation linked to validation activities.
* Ensure planification and prioritization of validation according to projects.
* Be the point of contact between different services (C&M, Maintenance, QA, EHS, business, legal inspection, …) within a project regarding validation aspects.
* Act as change Control coordinator to support the business in setting up facility and equipment related changes in the respective GSK system.
* Management of SAP systems and other validated electronic tools or requests related to validation activities.
* Anticipate and escalate problems and solutions for arising issues.
* Archive documentary packages associated to validation files.
* Propose process management improvement.
About you
* Bachelor's degree (technical science) and minimum 5 years of experience
* 3 years of experience in similar roles within the pharmaceutical industry (i.e. R&D, manufacturing, Quality)
* Engagement of numerous partners acting on validation projects requires good communication and engagement skills
* Ability to work autonomously
* Language skills: fluent in French and English – reading/writing/speaking
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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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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