Roles & Responsibilities
• Handle Quality Management System (QMS) activities including Deviations, CAPA, Change Control, and OOS/OOT documentation
• Ensure compliance with cGMP, regulatory guidelines, and internal SOPs
• Prepare, review, and maintain quality documents and records in line with injectable manufacturing standards
• Support internal audits, regulatory inspections, and compliance assessments
• Coordinate with QC, Production, and Engineering teams for investigation closure and corrective actions
• Monitor effectiveness of implemented CAPA and quality improvements
• Support continuous improvement initiatives within the quality system
Qualification
• B.Pharm or M.Pharm (preferred)
Experience
• Experience in QMS activities within pharmaceutical manufacturing
• Prior exposure to injectable/sterile facilities is preferred
• Freshers with strong academic background and interest in QA/QMS may also be considered
Skills
• Good understanding of QMS, GMP, and regulatory requirements
• Knowledge of deviation management, CAPA, and change control systems
• Strong documentation and compliance skills
• Attention to detail and problem-solving ability
• Good communication and coordination skills
About the Company
Nitin Lifesciences Limited is a reputed pharmaceutical company specializing in sterile injectable formulations, known for its quality-driven manufacturing practices and compliance with global regulatory standards, offering professionals a stable and growth-oriented career environment in injectable manufacturing.