Quality Compliance

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.