Description

1. Job Purpose To support Development Quality Assurance activities for CSBU-R&D; by ensuring compliance with applicable GMP, quality systems, regulatory requirements, and internal procedures across pharmaceutical development activities. The role involves review, monitoring, documentation, deviation management, and quality oversight of R&D; processes to ensure products are developed in accordance with defined quality standards. 2. Key Responsibilities A. Quality Assurance & Compliance * Ensure compliance with applicable GMP, GLP, regulatory guidelines, and internal quality systems. * Provide QA oversight for pharmaceutical development activities and associated documentation. * Review and approve/recommend approval of R&D; documents as per defined procedures and authorization matrix. * Ensure adherence to SOPs, policies, specifications, protocols, and established quality standards. * Support implementation and continuous improvement of quality systems within CSBU-R&D.; ### B. Documentation & Data Review * Review development protocols, reports, specifications, analytical documents, batch records, and other quality-related documents. * Ensure documentation is complete, accurate, traceable, and compliant with ALCOA+ principles. * Review laboratory and development data for completeness and integrity.



* Maintain appropriate quality records and ensure timely closure of documentation activities. C. Deviation, CAPA & Change Control * Support investigation and review of deviations, incidents, OOS/OOT and other quality events. * Participate in root-cause analysis and evaluation of CAPA effectiveness. * Review and monitor change controls impacting R&D; activities. * Ensure timely implementation and closure of assigned CAPA and quality actions. D. Audits & Inspection Readiness * Support internal audits, self-inspections, customer audits, and regulatory inspections. * Coordinate with R&D; stakeholders to ensure timely closure of audit observations. * Monitor compliance gaps and support preparation of appropriate action plans. * Ensure continuous inspection readiness within the assigned R&D; functions. E. Quality Risk Management * Participate in quality risk assessments related to development activities. * Identify potential quality and compliance risks and recommend appropriate controls. * Support implementation of risk-based quality management practices. F. Training & Quality Culture * Support identification of GMP and quality training requirements for R&D; employees. * Conduct/coordinate quality-related awareness and training programs. Promote a robust quality culture and compliance mindset across R&D; teams.

📌 Senior Executive (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka