Responsibilities may include the following and other duties may be assigned:

• Supports the development, modification, application and maintenance of quality standards and procedures for manufacturing processes and finished products.
• Works collaboratively with Engineering, Manufacturing and Quality teams to ensure compliance with quality system requirements.
• Collaborate with required stakeholders in the receive inspection function and across functions ensuring incoming materials and components meet defined specifications and regulatory requirements.
• Assists in implementing and maintaining product control measures to ensure product quality and patient safety.
• Reviews quality data, identifies trends and supports problem-solving activities to address quality issues.
• Supports inspection and testing activities and assists in the analysis of product and process performance.
• Applies and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of raw materials and test equipment
• Ensure quality records and documentation are completed accurately and maintained in compliance with applicable regulatory and internal requirements.
• Participate in preparing and facilitating investigations, providing QA technical direction and solutions as appropriate.
• Contributes to continuous improvement initiatives to enhance product quality, process effectiveness and operational performance.
• Supporting internal and external audits (BSI/MDSAP/FDA etc.).

Key Responsibilities:

• Maintain and oversee the company’s GDP Quality Management System, SOPs, and regulatory compliance.
• Act as the primary contact for the HPRA and lead regulatory inspection readiness and audits.
• Serve as the Controlled Drug Responsible Officer for specified distribution facilities.
• Oversee supplier/customer bona fides verification, product recalls, and CAPA/non-conformance decisions.
• Lead, mentor, and deliver annual GDP training across cross-functional teams.
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