QC Compliance Specialist: On-Site 12-Month Contract

Sanofi; Munster; Presencial; EUR 40.000 - 60.000; A tiempo parcial

Descripción de la vacante

Sanofi Waterford is seeking a QC Compliance Specialist to ensure robust QC processes on site and uphold cGMP standards. The role involves representing QC in QMS activities, timely investigation of events, implementing CAPAs, and coordinating across QC and other functions to close actions.

You will contribute to developing and maintaining an effective QC compliance program, issue and approve local QC documentation, and support regulatory inspections with a proactive, cross-functional approach.

Formación

• Degree in science or related discipline preferred.
• Experience in quality control within the pharmaceutical industry and GMP knowledge.
• Experience managing internal audits and external regulatory inspections.
• Understanding of pharmaceutical regulations, guidelines, and standards (FDA, EMA, ICH).
• Ability to analyze compliance issues, identify root causes, and implement solutions.
• Proficiency in identifying issues and implementing effective solutions to QC problems.
• Strong verbal and written communication to convey compliance requirements.

Responsabilidades

• Represent QC for processes led by QMS at site level.
• Investigate quality control events and implement CAPAs.
• Manage follow-up and progress tracking of deviations, lab investigations, change control, and CAPAs.
• Contribute to develop, implement, and maintain an effective QC compliance program.
• Ensure issuance and approval of local quality control documentation to support QMS processes.
• Investigate timely quality control events and implement remediation actions.
• Provide support during regulatory inspections and audits.
• Lead initiatives for continuous improvement in QC with the QC excellence team.
• Ensure compliance to cGMP at all times.

Conocimientos

Quality control

GMP knowledge

Regulatory inspections

Audits

Root-cause analysis

Communication skills

Educación

Science degree (Third Level)

Descripción del empleo

Sanofi Waterford is seeking a QC Compliance Specialist to ensure robust QC processes on site and uphold cGMP standards. The role involves representing QC in QMS activities, timely investigation of events, implementing CAPAs, and coordinating across QC and other functions to close actions.

You will contribute to developing and maintaining an effective QC compliance program, issue and approve local QC documentation, and support regulatory inspections with a proactive, cross-functional approach.