CQA Head | Pharma

Job Description : CQA Head | Pharma Industry IRELAND Experience: 25+ Years Open to International candidates Minimum 25+ years of experience in the Pharmaceutical Industry. Must have strong experience in Corporate Quality Assurance (CQA). Mandatory exposure to Injectable Manufacturing Plants. Strong understanding of cGMP, GDP, Quality Management Systems, and Regulatory Compliance. Experience in handling quality operations across pharmaceutical manufacturing facilities. Strong leadership, communication, and team management skills. Roles & Responsibilities: Lead and manage the overall Corporate Quality Assurance (CQA) function. Develop, implement, review, and strengthen the Quality Management System (QMS) across the organization. Ensure compliance with cGMP, WHO-GMP, Schedule M, and other applicable regulatory requirements. Review and approve quality-related documents, including SOPs, policies, protocols, and quality procedures. Oversee and monitor Deviations, CAPA, Change Controls, OOS, OOT, Risk Assessments, and Quality Investigations. Ensure effective implementation of Data Integrity and Good Documentation Practices. Conduct and coordinate internal audits, external audits, vendor audits, and regulatory inspections. Support manufacturing sites in maintaining inspection readiness and regulatory compliance. Review audit observations and ensure timely implementation and closure of corrective and preventive actions. Provide quality guidance and support to QA, QC, Production, Engineering, Warehouse, and other cross-functional departments. Monitor key quality metrics and identify opportunities for continuous improvement. Lead and mentor the Quality Assurance team and ensure effective implementation of quality systems. Drive a strong quality culture and compliance-focused environment across the organization.

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