Quality Assurance Specialist
3 days ago
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Quality Assurance Specialist to join their team to support multiple capital projects taking place onsite.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Role Summary:
Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems. Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same. Support the development and implementation of improved quality reporting measures. Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process. Provide effective real time on the floor support for day-to-day manufacturing operations for example area clearances, batch record reviews, aseptic operations. Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained. Provide training in all aspects of Quality Management Systems and GMP. Ensure all work is carried out in line with SOP's, training, or other quality systems such as change controls where applicable. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
Experience, Knowledge & Skills:
Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site. GMP Audit experience in the pharmaceutical industry Third Level Degree qualified in a Science/Technical or related discipline. If this role is of interest to you, please apply now
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