QA Associate Specialist - Shift

QA Associate Specialist - Shift
RK22685
Contract – 11 months
On site - Carlow



We’re currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period.



Duties

• Responsible for ensuring manufacturing of drug products is in compliance with cGMP and associated regulatory requirements
• Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
• Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to customers.
• Review and approval of batch documentation, SOPs, cleaning verification and validation data, training and other QMS documentation
• Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
• Provide quality oversight including training on all aspects of QMS and GMP and provide quality support for day to day operations
• Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
• Participate in Plant/Quality committees to help set the direction for plant wide GMP initiatives

• Third Level Degree qualified in a Science/Technical or related discipline.
• GMP audit experience in pharmaceutical industry
• 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.
• Report, standards, policy writing skills required.