Site Corporate Quality Lead

Job Overview

We are currently recruiting for Site Corporate Quality Lead within our Corporate QA department. The purpose of the role is to set and monitor Key Performance Indicators for quality at operational business units. The candidate will also perform quality reviews of operational business units to cGMP and escalate identified excursions from expectations to senior site operational and quality management.

Key Skills

• Excellent knowledge of EU and US GMP
• Good communication skills; oral and written, e.g., interpersonal and technical report writing skills.
• Participate as part of a cross functional team
• Good planning and organisational skills with the ability to prioritise and work effectively on multiple tasks.
• Strong data interpretation and problem solving skills.
• Ability to lead projects where members are drawn cross-functionally

Main Activities/Tasks

• Based on a rotational basis at individual operational business units, monitor quality performance of the operational units to cGMP and escalate identified issues to site leadership (quality and operational) for further action.
• Ensure that plans are provided by the operational business unit owners to address all identified discrepancies from expected quality performance.
• Check effectiveness of corrective plans.
• Perform internal quality audits as assigned by Internal Audit management. To participate in manufacturer, supplier and sub-contractor audits as required.
• Identify key performance indicators for site operational quality performance and communicate these and monitor and report on the KPIs.
• Supply regular reports of KPI statistics and observations to the Senior Management.
• Manage any assigned market actions associated with the operational business units and ensure that site operational business unit leadership provide reports and CAPAs on a timely basis to meet the expected timeframes.
• Reviewing and where appropriate approving or authorizing SOPs or other GMP documents where appropriate.
• To participate in customer and competent authority audits of Norbrook as required.
• To undertake any ad hoc duties as required to sustain improvement and compliance of the quality system in Norbrook Laboratories Ltd.

Essential Criteria:

• Minimum five years’ experience in a quality auditing or operations quality assurance role in the pharmaceutical industry.
• Third level qualification (a scientific or engineering discipline would be preferred but not essential)
• Excellent working knowledge of current Good Manufacturing Practices (cGMP) for both EU and US
• Experience identifying and investigation of excursions from GMP and the implementation of corrective actions
• Experience of leading or participating in Quality Management System audits.

Desirable Criteria:

• Knowledge of sterile and non-sterile pharmaceutical product manufacturing, filling processes and analytical processes.
• Knowledge of validation activities/methodologies
• Experience leading a Quality Assurance function in an operational/production environment
• Experience of field market actions such as product defect reporting, batch/product recall activities

Location: Newry, Co. Down

Remuneration: Salary Attractive

Contact: The Human Resources Department

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.