Associate QA Specialist (Shift)
AMC20711
11 Months
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.




Duties:

• 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.
• 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 SOP’s, 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.

• 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