Quality Assurance Specialist

Quality Assurance Specialist - Pharma - Carlow, Ireland - 11-Month Contract

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 :

If this role is of interest to you, please apply now!

LI-CH3