AGM – CQA

Job Description : AGM – CQA IRELAND Corporate Office, Dublin Ireland Open to International candidates Experienced Corporate Quality Assurance (CQA) professional with strong expertise in SOP harmonization, formulations manufacturing, Engineering – Equipment & Utilities qualification, and Computerized System Validation (CSV). Provide expertise in SOP harmonization, particularly related to Engineering, including Equipment & Utilities qualification. Demonstrate strong understanding of formulations manufacturing processes and associated quality systems. Lead end?to?end validation of computerized systems, ensuring compliance with GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5 from system initiation through retirement. Drive implementation and validation of LIMS applications, ensuring data integrity, regulatory compliance, and minimal business disruption. Prepare, review, and approve validation documentation, including: VMP, URS, FRS DQ, IQ, OQ, PQ Traceability matrices and validation summary reports Conduct system assessments, risk assessments, and gap analyses, and define, implement, and close CAPAs. Perform periodic audit trail reviews and manage LIMS-related SOPs and user training across multiple sites. Collaborate with vendors and service providers to resolve system issues and ensure ongoing system reliability. Harmonize SOPs and quality systems across multiple manufacturing locations. Support internal, corporate, regulatory, and vendor audits. Deliver training programs on cGMP, compliance expectations, regulatory updates, and inspection observations. M.Pharm 18+ years of experience in Corporate Quality Assurance (CQA) within the pharmaceutical industry. SOP harmonization Formulations manufacturing exposure Engineering, Equipment & Utilities qualification Computerized System Validation (CSV) LIMS validation and data integrity Strong regulatory and audit?handling capabilities

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