QA Specialists

Role Summary:

QA Specialists required for a pharmaceutical client based in Waterford:

• Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
• Support the development of GMP training packages and delivery of training
• Participate in the preparation and review of procedures and batch documentation
• Perform audits of all departments to agreed schedule
• Ensure the quality system at Genzyme is effectively implemented and maintained
• Ensure practices meet cGMP requirements

Core Duties and Responsibilities:

• Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
• Perform timely review of documentation / investigations /reports highlighting and assisting in the resolution of concerns commensurate with the risk
• Work with relevant departments to ensure timely closure of quality actions / findings
• Actively contribute to continuous improvement initiatives.
• Conduct duties in a safe manner and report all safety issues or concerns
• Maintain work area to good housekeeping standards
• Ensure attendance at place of work when required
• Support team in achieving team goals/targets
• Attend team meetings as required
• Actively contribute to continuous improvement initiatives
• Measure and report RFT / trend data and work with departments to resolve recurring issues
• Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
• Perform critical/ constructive review of procedures and practices
• Support investigation of deviations ensuring all product deviations are closed prior to product release
• Ensure compliance to cGMP at all times

Minimum Qualifications and Experience:

• Third Level qualification (degree in science or related discipline preferred).
• Minimum of 2 years’ experience in a similar role
• Experience working in a GMP environment is required
• Very good knowledge of cGMP in a regulated environment
• Excellent accuracy and attention to detail
• Excellent interpersonal skills
• Good presentation skills
• Working knowledge of computer packages
• Flexible approach – comfortable with on-going change

Please note, we do not require agency assistance with this role.