Overview
Associate QA Specialist (Shift) – Job ID AMC2071111 – Carlow. We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Responsibilities
* Review and approval of all manufacturing batch documentation including electronic batch records, real-time reports, and master data using the site systems.
* Review and approval of SOPs, 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.
* Verification of the effective implementation of key GMP programs.
* Effectiveness of Preventative Actions.
* Provide training in all aspects of Quality Management Systems and GMP.
* Ensure all work is carried out in line with SOPs, training or other quality systems such as change controls where applicable.
* Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same, ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
Education and Experience
* Third Level Degree qualified in a Science/Technical or related discipline.
* 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.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.
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