Executive/Sr Executive - IPQA

As a member of the team at Biocon Biologics Limited, a subsidiary of Biocon Limited, you will be part of a fully integrated global biosimilars organization dedicated to leveraging cutting-edge science, innovative tech platforms, and advanced research & development capabilities to enhance healthcare outcomes while reducing treatment costs. With a strong research pipeline focusing on biosimilar molecules across various therapeutic areas such as diabetes, oncology, immunology, and other non-communicable diseases, Biocon Biologics has successfully brought six molecules from its portfolio to market in developed regions like the United States, EU, Australia, Canada, and Japan. With a workforce of approximately 4,800 individuals, Biocon Biologics is committed to revolutionizing healthcare and improving the lives of millions of patients worldwide through affordable access to quality treatment options. Key Responsibilities: - Performing line clearance for formulation, washing, filling, sealing, and other manufacturing activities. - Reviewing and approving execution reports for various processes including formulation, sterilization, filtration, filling, sealing, integrity testing, and reconciliation. - Collecting and submitting samples for in-process checks, finished product analysis, and process validation. - Reviewing batch manufacturing records, protocols, and other Good Manufacturing Practice (GMP) documents. - Reviewing and approving validation/study protocols, reports, master batch records, and Standard Operating Procedures (SOPs). - Investigating complaints, deviations, out-of-specifications results, and other quality-related issues. - Providing oversight on media fill procedures, aseptic practices, microbial monitoring, and clean room maintenance. - Conducting an overview of manufacturing and filling equipment, including utilities such as water systems, HVAC, compressed air, and steam plants. Qualifications Required: - Bachelor's degree in a relevant scientific discipline or equivalent educational background. - Prior experience in a pharmaceutical manufacturing environment, particularly in roles related to quality assurance or quality control. - Strong understanding of GMP regulations and industry best practices. - Excellent attention to detail, analytical skills, and problem-solving abilities. - Effective communication skills and the ability to work collaboratively in a team-based setting. (Note: Additional details about the company were not present in the provided job description.),