MES Quality Compliance Lead

Cpl Group; Limerick; On-site; EUR 65,000 - 85,000; Full time

Job summary

Kenny-Whelan (A specialist division of the CPL group) seeks a QA Rep (MES) to be based at a Pharmaceutical Plant in Limerick. You will provide Quality leadership for MES systems, investigate MES issues, and manage quality matters in the GMP environment.

You will support audit logistics and ensure compliance with regulatory commitments across the Quality System. Applicants should have a relevant degree (BSc/MSc/PhD) in Chemistry, Engineering or related discipline and experience in GMP/MES

Qualifications

• Experience leading MES quality activities.
• Strong GMP/regulatory knowledge and decision making.
• Ability to support audits and cross-functional teams.
• Experience with change controls, deviations and investigations.
• Familiarity with CSV deliverables and quality documentation.

Responsibilities

• Provide Quality direction for MES systems and governance.
• Participate in QA meetings and communicate MES initiatives.
• Contribute to GMP/Quality plans for quality system initiatives.
• Ensure validated state of Quality systems and regulatory alignment.
• Review/change controls, deviations, investigations and CSF deliverables.

Skills

Quality leadership

GMP compliance

MES systems

Audit support

Regulatory interpretation

Education

BSc in Chemistry or Engineering

MSc or PhD in related discipline

Job description

Kenny-Whelan (A specialist division of the CPL group) seeks a QA Rep (MES) to be based at a Pharmaceutical Plant in Limerick. You will provide Quality leadership for MES systems, investigate MES issues, and manage quality matters in the GMP environment.

You will support audit logistics and ensure compliance with regulatory commitments across the Quality System. Applicants should have a relevant degree (BSc/MSc/PhD) in Chemistry, Engineering or related discipline and experience in GMP/MES