Senior Quality Assurance Officer

Overview

Our client is a leading manufacturer in the pharmaceutical industry. They are committed to maintaining the highest standards of quality in their manufacturing processes. They manufacture a range of medicinal products including liquid, semi solid and solid dosage products.

They are looking to add 2 Senior Quality Assurance Officers to their expanding team. You will work within a multi-disciplinary team to take a tactical role in the design, implementation, and establishment of suitable governance processes to assure the consistent GMP compliance of the GMP manufacturing facility. This is a full on site position in South Dublin.

Responsibilities

• Promote the awareness of quality requirements and support the evolution of the quality culture throughout the company and educate staff in quality related activities where appropriate.
• Maintain processes, including GMP document control (i.e. Batch review, issuance of document) and training, needed for successful site compliance to the PQS.
• Participate in the review performance of the PQS at planned intervals and provide regular reporting to ensure its continuing suitability, adequacy, and effectiveness and where appropriate, propose improvements.
• Participate in the execution of a GMP internal Audit/self-inspection programme, including identification and implementation of appropriate corrective actions and the process to track their completion via the change management system.
• Monitor and coordinate completion of GxP Audit PQS records (i.e., change controls, deviations and CAPAs) maintained within the QMS.
• Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes via the PQS.
• Work with other elements of the QMS and the QA team as required to support site compliance, business KPIs, and continuous improvements.
• Administration of the Quality Management System including allocation of document numbers, event numbers and maintenance of the associated logs.
• Ensure company compliance of Good Documentation Practices, maintenance of signature logs and company initials register.
• Notify document owners in a timely manner of pending SOPs/forms requiring review and track progress until completion.
• Responsible for issuance, obsolescence and archiving of the clients QMS documents.
• Creation, review and approval of Quality documents.

Requirements

• BSc or equivalent in scientific discipline.
• Understanding of GMPs and GDPs.
• Ability to manage multiple and varies tasks and prioritize workload with attention to detail.
• 3 to 8 years QA experience working within a GMP setting.
• Ability to apply risk-based approach for pragmatic problem solving.
• Strong organisational skills.
• Strong time management for the control of self-workload.
• Good team player.
• Flexible in supporting business needs.