Overview
Quality Assurance Specialist Jobs in Carlow, County Carlow, Ireland at Life Science Recruitment
Title: Quality Assurance Specialist
Company: Life Science Recruitment
Location: Carlow, County Carlow, Ireland
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
Education & Experience
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.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
