QC Compliance Specialist

Summary:
Our client, a bio pharmaceutical company located in Waterford, is currently looking for a QC Compliance Specialist. The successful candidate will be responsible for the raising, management and on time closure of all Quality System processes including assigned Change Controls, Deviations, CAPAs, ILIs (inline inspection) & QEs.

Responsibilities:

• Driving of all Quality Metrics for the department.
• Forward review of Quality Metrics to ensure no over-dues.
• Procedure effectiveness and simplification and actively contribute to continuous improvement initiative.
• Ensure effective co-ordination and support for external and internal audits for the department.
• Perform critical / constructive review of procedures and practices.
• Identify and lead projects to make step change improvements to the department’s Quality.
• Conduct duties in a safe manner and report all safety issues or concerns.
• Support leadership team in achieving goals / tasks.
• Actively contribute to continuous improvement initiatives utilising lean methodologies where appropriate.
• Liaise with Quality Assurance Representative to support and improve RFT in the area and Always Audit Ready.
• Ensure all required training is completed on time.
• Maintain training in critical test activities as required in the laboratory as defined by head of QC.

Qualifications & Experience:

• Degree in Science or Quality Engineering.
• 2-3 years’ experience in a similar GMP regulated environment.
• Working experience of quality systems and processes.
• Excellent documentation skills.