Key Responsibilities: Implement and maintain robust Quality Management System (QMS) processes in compliance with national and international pharmaceutical regulatory standards for Sanolet Lifecare Private Limited's manufacturing facility in Ahmedabad, Gujarat. Oversee in-process quality assurance activities, line clearances, and sampling for Injectables & Sterile Products, ensuring adherence to GMP and GLP in a dynamic industrial manufacturing environment. Review and approve critical quality documents including Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Standard Operating Procedures (SOPs), and specifications related to sterile manufacturing operations. Conduct thorough investigations into deviations, non-conformances, and market complaints, identifying root causes and facilitating the implementation of effective Corrective and Preventive Actions (CAPA) within the Sanolet Lifecare quality framework. Actively participate in internal audits, self-inspections, and support regulatory agency inspections, ensuring the site's readiness and continuous compliance for sterile product manufacturing. Collaborate with production and other cross-functional teams within the 51-100 employee structure to foster a strong quality culture, providing training and guidance on quality-related procedures specific to pharmaceutical sterile operations. Essential Requirements: Bachelor's or Master's degree in Pharmacy, Pharmaceutical Technology, or a related life sciences discipline from a recognized institution. Minimum 3 years and maximum 5 years of experience required, specifically within the Quality Assurance or Quality Control department of a pharmaceutical manufacturing company dealing with Injectables & Sterile Products. In-depth knowledge of current Good Manufacturing Practices (cGMP), ICH guidelines, and regulatory requirements (e.g., USFDA, MHRA, WHO-GMP) pertinent to sterile product manufacturing and industrial operations. Demonstrated technical expertise and hands-on experience with quality systems applied to Injectables & Sterile Products, including environmental monitoring, sterility assurance, and media fill protocols. Strong analytical and problem-solving skills to effectively address quality issues, perform risk assessments, and drive continuous improvement within a dynamic manufacturing environment. Excellent communication, teamwork, and interpersonal skills essential for collaborating within a mid-sized company like Sanolet Lifecare Private Limited.