Quality Compliance

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

Quality Rep MES

Kenny-Whelan (A specialist division of the CPL group) are hiring a QA Rep (MES) to be based at our clients Pharmaceutical Plant in Limerick.

Main Purpose and Objectives of Position:

• Provide Quality leadership, direction, and governance for MES and MES related systems.
• Investigate and troubleshoot issues relating to MES and MES related systems.
• Manage Quality-related matters specific to area (Quality system or Quality Program) of responsibility.
• Approve appropriate quality-related documents. An approval signature confirms that Lilly and GMP requirements have been met.
• Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices and promptly report any safety concerns.
• Promote and encourage Quality culture and promptly report any compliance concerns.

Scope:

May hold BSc, MSc or PhD in Chemistry, Engineering, or related discipline.

Key Responsibilities:

• Provide Quality direction and oversight for MES systems.
• Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP MES systems.
• Contribution to the Quality Plan (GMP Plan) for specific Quality System/ Programme Initiatives.
• Provide backup cover in the case of absence for any identified roles.
• Assure consistent implementation of standards across the Quality System.
• Assure that the Quality system(s)/Program remains in a validated state and aligned within regulatory commitments.
• Interpretation and application of emerging Regulatory & GMP guidelines to the specific Quality System(s)/Program.
• Support audit logistics from an MES perspective.
• Support cross functional teams in audit preparation activities.
• Carry out audit trails reviews as per site procedures.
• Liaise with Global Quality Standard owner when deemed necessary.
• Review and approval of change controls, deviations, failure investigations, if applicable.
• Report and escalation critical quality issues to appropriate level of quality management for resolution.
• Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
• Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
• Participation in the site self-inspection program of the area(s) of responsibility for compliance with the GQS & local procedures.
• Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility.