Quality Assurance Specialist
Days & hybrid
RK26586
Contract 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.



Key Responsibilities:

• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original,and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable cGMP training.
• Responds to Operational and business area’s, drives compliance with cGMP and corporate regulations.
• Drives cGMP/GDP compliance in the performance of day-to-day business activities.
• Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products and aids resolution
• Liaise with the Quality/ Business Area Specialists/QP/QA Lead to resolve quality related queries where required
• Provides expertise & quality support for the introduction of new products onto site in relation to product release where required
• Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
• Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
• Review and approval of all manufacturing batch/ material documentation including electronic batch records, real time reports, master data using the site systems where required.
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.

• Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
• 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
• Demonstrated experience working within Quality Systems and Compliance functions, including management of quality records, deviations, CAPAs, change controls, investigations, Complaints and document management systems.
• Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations.