Quality Rep (SCM)

Cpl Group; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

Kenny-Whelan (A specialist division of the CPL group) is hiring a QA Rep (Supply Chain Management) to lead quality matters at the Limerick pharmaceutical plant. The role requires ensuring GMP compliance, approving quality documents and maintaining control systems across the quality program.

The successful candidate will manage supplier-related quality activities, review change controls, conduct audits of vendors, and drive continuous improvements within the quality framework.

Qualifications

• Quality leadership and governance for the area of responsibility.
• Knowledge of GMP requirements and regulatory guidelines.
• Experience with supplier management and quality systems.

Responsibilities

• Benchmark current and emerging quality initiatives in the program.
• Own, review or approve change controls and deviations related to supplier management.
• Report and escalate critical quality issues to quality management for resolution.
• Monitor GMP compliance and programs through regular site presence.
• Evaluate and approve 3rd party suppliers/contractors for the area.
• Maintain vendor files, audit plans and supplier evaluations.

Skills

Quality leadership

GMP compliance

Supplier management

Change controls

Education

Biotech/Chemistry/Engineering degree

Job description

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

Main Purpose and Objectives of Position:

Provide Quality leadership, direction and governance for the specific area of responsibility.

Manage quality-related matters specific to area of responsibility

Responsible for approving appropriate quality-related documents. Approval signature confirms that Lilly and GMP requirements have been met.

Carry out day to day activities in compliance with site safety policy and procedure.Promote and encourage safe practices and promptly report any safety concerns.

Assures consistent implementation of standards across the quality system.

Maintenance of all aspects of GMP compliance for the area(s) of responsibility.

Establishment, maintenance and management of a control system for the specific Quality System(s)/Program.

Interpretation and application of emerging regulatory & GMP guidelines to the specific Quality System(s)/Program

Key Responsibilities:

• Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
• Own, review or approve change controls (including implementation steps), deviations (including tasks) associated with Supplier Management.
• Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.
• Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in the area of responsibility.
• Evaluation, audit and approval of 3rd party suppliers/contractors as appropriate for the area of responsibility.
• Contribution to the Quality plan for specific quality system/program initiatives.
• Maintains the vendor files for service providers, materials and consumables (generation of audit plans and Q agreements, assists in scheduling of local, national and international audits, manage vendor file periodic reviews as per local SOP, ensure all vendor file content is current and appropriately documented, monitor and modify the supplier evaluation process as required).
• Generate and maintain vendor files for materials (liaise with purchasing to define supply chain, complete risk assessments in conjunction with procurement and MS&T, participate in the new item code process, approval of material and vendor package, re-evaluation of vendors

Educational Requirements:

BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline, with a minimum of 3 years relevant experience.