Pharma Quality Assurance Specialist
Our pharmaceutical client is seeking a skilled Quality Assurance Specialist to join their team in Carlow, Ireland. This 11-month contract opportunity involves working on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
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* Review and approval of manufacturing batch documentation, including electronic batch records, real-time reports, and master data using site systems.
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* Review and approval of SOPs, cleaning verification/validation data, and other documents for the IPT department.
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* Develop and implement accurate operational procedures, training materials, and maintenance procedures for quality-related systems.
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* Support the development and implementation of improved quality reporting measures.
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* Liaise with Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing processes.
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* Provide real-time support for day-to-day manufacturing operations, including area clearances, batch record reviews, and aseptic operations.
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* Ensure product quality by providing quality input into decision-making processes.
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* Provide training in all aspects of quality management systems and GMP.
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* Facilitate compliance direction by assisting in adherence to divisional policies and guidelines as well as regulatory requirements.
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Requirements:
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* Relevant experience in a quality role, preferably in a pharmaceutical manufacturing environment.
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* Knowledge of US and European cGMP guidelines, and other international regulatory requirements.
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* GMP audit experience in the pharmaceutical industry.
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* Third-level degree qualified in a science/technical or related discipline.
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