Corporate Quality Assurance

3 days ago

New Delhi, India RESONACLE Full time

We are seeking a highly experienced Quality Assurance leader to driveCorporate QA initiativesacross multiple formulation manufacturing sites. The incumbent will be responsible for strengthening the company’sAudit, Compliance, and Validation/Qualification (VQ)framework, ensuring adherence to global regulatory standards, and maintaining continuousinspection readiness.This is astrategic corporate rolerequiring close coordination with site QA, manufacturing, and regulatory teams to uphold a consistent culture of quality excellence and compliance across all units.Key Responsibilities: Lead and manageinternal and external auditsacross formulation sites (OSD, Injectables, Topicals). Ensure full compliance withUSFDA, MHRA, EU, ANVISA, TGA, and WHOregulatory requirements. Overseeaudit preparedness, inspection readiness, and CAPA effectiveness. Develop and implementcorporate QA policies, SOPs, and governance frameworks. Review and monitorsite-level quality metricsand compliance dashboards. Collaborate with site QA teams tostandardize systemsand close quality gaps. Review and approvevalidation protocols, change controls, deviations, and risk assessments. Ensure alignment of VQ activities withGMP, ICH, and data integrityrequirements. Design and delivertraining programson compliance, audit management, and regulatory awareness. Act as acorporate liaisonduring regulatory inspections and manage post-inspection communications.Key Requirements: Education:B.Pharm / M.Pharm / M.Sc. (Life Sciences) or equivalent. Experience:15+ years in Corporate QA within thepharmaceutical formulationsindustry. Proven exposure toglobal regulatory audits(USFDA, EU, MHRA, ANVISA, TGA). Strong understanding ofGMP, ICH, QMS, and data integrityprinciples. Hands-on experience withCAPA systems, documentation review, and validation oversight. Excellentleadership, communication, and stakeholder managementskills. Ability to travel to multiple manufacturing sites as required.

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