Senior Quality Assurance Analyst

Our client, a leading pharmaceutical company in **Nagpur, Maharashtra, IN**, is seeking a highly experienced Senior Quality Assurance Analyst to join their vital Quality Unit. This role is essential for upholding the stringent quality standards required in the pharmaceutical industry, ensuring compliance with national and international regulatory guidelines. The Senior QA Analyst will be responsible for developing, implementing, and maintaining quality assurance systems, performing batch record reviews, managing deviations and CAPAs, and conducting internal audits. Your expertise will be critical in ensuring the safety, efficacy, and consistency of our pharmaceutical products.

Key Responsibilities:

Review and approve Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) to ensure compliance with procedures and specifications. Investigate deviations, out-of-specification (OOS) results, and out-of-trend (OOT) data, and implement Corrective and Preventive Actions (CAPAs). Develop, revise, and approve Standard Operating Procedures (SOPs), validation protocols, and other quality-related documents. Conduct internal audits of manufacturing processes, quality control laboratories, and warehousing operations. Participate in external audits by regulatory agencies (e.g., FDA, WHO GMP) and customers. Manage change control processes, ensuring all changes are properly evaluated, documented, and approved. Oversee vendor qualification and management processes. Train personnel on quality systems, GMP requirements, and compliance procedures. Monitor quality metrics and prepare reports for management review. Contribute to continuous improvement initiatives within the quality management system. Ensure compliance with all applicable regulatory requirements, including Indian GMP, US FDA, and ICH guidelines. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related life science field. A minimum of 6 years of experience in Quality Assurance within the pharmaceutical industry is required. Strong knowledge of Good Manufacturing Practices (GMP), regulatory requirements, and quality management systems is essential. Excellent analytical, problem-solving, and decision-making skills are crucial. Proficient in conducting investigations, root cause analysis, and CAPA management. Exceptional attention to detail and strong documentation skills are necessary. The ability to work effectively in a team and communicate clearly with various departments is important for this role based in **Nagpur, Maharashtra, IN**.