Pharmaceutical Quality Assurance Leader

5 days ago


Dublin, Dublin City, Ireland West Pharmaceutical Services, Inc Full time

Key Responsibilities:

The Pharmaceutical Quality Assurance Leader will be responsible for ensuring all products and processes comply with relevant regulations and guidelines. This includes developing, implementing, and maintaining the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.

In addition to ensuring regulatory compliance, this role will also oversee the management of SOPs, Work Instructions, and other quality-related documentation. The Quality Assurance Leader will lead internal audits and participate in external audits and regulatory inspections, preparing audit reports and managing corrective and preventive actions (CAPAs).

The Quality Assurance Leader will also develop and execute training programs for staff on quality-related topics, monitor the effectiveness of training programs, and maintain training records. Furthermore, this role will oversee quality control processes, including raw material testing, in-process monitoring, and final product testing, ensuring all quality control activities are documented and carried out in accordance with established procedures.

This position requires collaboration with the Qualified Person (QP) to ensure batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards. Additionally, the Quality Assurance Leader will promote a culture of continuous improvement by identifying areas for improvement and implementing effective solutions, using quality metrics and data analysis to drive process improvements and enhance product quality.

The Quality Assurance Leader will also evaluate and qualify suppliers and contractors to ensure they meet the company's quality standards, managing supplier audits and assessments to maintain a high level of quality throughout the supply chain.



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