QA Specialist - Sterile Manufacturing We’re currently recruiting for an excellent Quality Assurance opportunity with a leading global pharmaceutical manufacturer based in Waterford.

The position will form part of the site Quality Assurance team, ensuring that products are manufactured, stored and packaged in accordance with cGMP requirements.
This role would be particularly relevant for a QA professional with experience supporting sterile, aseptic or other highly regulated pharmaceutical manufacturing operations.
Duties

• Act as the quality point person for assigned manufacturing systems and processes.
• Provide quality guidance and feedback to manufacturing and supporting departments.
• Review batch documentation, investigations, reports and GMP records within agreed timelines.
• Identify quality concerns and support their resolution based on product and compliance risk.
• Support deviation investigations and ensure product-impacting deviations are closed before release.
• Work with relevant departments to ensure timely closure of CAPAs, audit findings and quality actions.
• Participate in the preparation and review of procedures, batch records and controlled documentation.
• Support the development and delivery of GMP training packages.
• Perform internal audits in accordance with the site audit schedule.
• Participate in supplier and regulatory audits where required.
• Monitor Right First Time performance and quality trends.
• Work with manufacturing departments to address recurring documentation and compliance issues.
• Support continuous improvement initiatives across the site quality system.
• Perform critical and constructive reviews of procedures and manufacturing practices.
• Ensure compliance with cGMP and site safety requirements at all times.

• A third-level qualification in science, quality, engineering or a related discipline.
• A minimum of two years’ experience in Quality Assurance or a comparable GMP quality role.
• Previous experience working within a pharmaceutical, biotechnology or other regulated manufacturing environment.
• Strong working knowledge of cGMP requirements.
• Sterile or aseptic manufacturing experience is highly desirable.
• Experience reviewing deviations, investigations, CAPAs and batch documentation would be advantageous.
• Excellent accuracy and attention to detail.
• Strong interpersonal, communication and presentation skills.
• Ability to work effectively across multiple departments.
• Comfortable working within a changing and continuously improving manufacturing environment.