Description

Perform quality checks and review of API manufacturing and testing activities. Ensure compliance with GMP, SOPs, specifications, and quality standards. Review batch manufacturing and analytical records for completeness and accuracy. Monitor and review in-process, finished product, and stability testing results. Handle and support investigations related to OOS, OOT, deviations, incidents, and complaints. Support CAPA implementation and effectiveness checks. Review and maintain quality-related documentation and records. Coordinate with Production, Quality Control, R&D;, Warehouse, and Regulatory Affairs teams. Ensure proper handling and documentation of changes through Change Control procedures. Participate in internal audits, customer audits, and regulatory inspections. Monitor compliance with data integrity requirements, including ALCOA+ principles. Assist in preparation and review of CoA, specifications, test methods, SOPs, and other quality documents. Ensure proper documentation and traceability of raw materials, intermediates, and APIs.



Support continuous improvement initiatives related to product quality and manufacturing processes. Required Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field. 1–3 years of relevant experience in API / pharmaceutical quality assurance or quality control. Good knowledge of GMP, GLP, SOPs, OOS/OOT, deviations, CAPA, Change Control, and audit requirements. Strong documentation and analytical skills. Positive understanding of pharmaceutical manufacturing and quality systems. Proficiency in MS Office and quality management/documentation systems. Key Skills Quality assurance and compliance GMP documentation Root Cause Analysis Deviation and OOS investigation CAPA management Change Control Audit readiness Data integrity Attention to detail Communication and coordination Problem-solving and analytical thinking

📌 Senior Officer (India)
🏢 Cadila Pharmaceuticals
📍 India