Job Summary
We are seeking a highly motivated QA Associate Specialist to join our team in Carlow.
This is an exciting opportunity to work with a leading multinational pharmaceutical organization at a time of significant growth and development.
Duties
* Ensure that the manufacture of drug products complies with current Good Manufacturing Practices (cGMP) and associated regulatory requirements.
* Review and approve GMP documentation to support corporate compliance and regulatory expectations for manufacturing operations.
* E nsure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to customers.
* Review and approval of batch documentation, Standard Operating Procedures (SOPs), cleaning verification and validation data, training and other Quality Management System (QMS) documentation.
* Liaise with 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, such as area clearances, batch record reviews and aseptic operations.
* Participate in Plant/Quality committees to help set the direction for plant-wide GMP initiatives.
Requirements
* Third-Level Degree qualified in a Science/Technical or related discipline.
* GMP audit experience in the 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.