GM

Job Description : GM – API Plant QA IRELAND Open to International candidate with 20+ years experience We are looking for experienced Quality Assurance professionals with strong exposure to API manufacturing operations and regulatory compliance. Key Responsibilities: • Lead and manage API Plant Quality Assurance activities • Ensure compliance with cGMP, regulatory guidelines, and quality systems • Handle batch review, investigation, deviations, CAPA, change control, and audit management • Monitor documentation practices and quality compliance across manufacturing operations • Coordinate with Production, QC, Regulatory, and Engineering teams for quality improvements • Support regulatory inspections and customer audits • Drive continuous improvement initiatives in quality systems and compliance standards Required Skills: • Strong exposure to API Plant QA operations • Knowledge of cGMP, USFDA, MHRA, EU GMP, and other regulatory standards • Experience in handling audits, investigations, deviations, and CAPA • Strong leadership, documentation, and stakeholder management skills Qualification: B.Pharm / M.Pharm / MSc or relevant qualification

---