KEY RESPONSIBILITIES Production Management : Oversee and manage day-to-day production operations to meet quality, cost, and delivery targets. Develop and implement production schedules to ensure the timely delivery of products. Ensure adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations. Regulatory Compliance : Maintain and ensure compliance with USFDA, WHO, and other regulatory standards in all production processes. Coordinate with the Quality Assurance (QA) team to prepare for and manage regulatory audits and inspections. Ensure proper documentation of all manufacturing processes as per USFDA requirements. Team Leadership : Lead, mentor, and train the production team to ensure optimal performance and awareness of regulatory requirements. Foster a culture of continuous improvement, accountability, and teamwork. Process Improvement : Identify and implement process optimizations to improve productivity, efficiency, and quality. Collaborate with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain to resolve production-related issues. Equipment and Facility Management : Ensure proper maintenance and calibration of production equipment and facilities. Implement safety protocols to maintain a hazard-free work environment. Resource Planning : Manage inventory of raw materials and ensure uninterrupted production. Prepare and manage the production budget to optimize costs without compromising quality Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field. Minimum of 5-7 experience in pharmaceutical manufacturing in a managerial role . Proven experience working in a USFDA-regulated environment, with knowledge of cGMP, CAPA, and regulatory submissions. Technical / Functional Skills Strong understanding of pharmaceutical production processes, including tablet, capsule, injectable, or API manufacturing. Familiarity with validation protocols, including IQ, OQ, and PQ processes. Exceptional leadership, communication, and interpersonal skills. Strong analytical, problem-solving, and decision-making abilities. Ability to work under pressure and meet tight deadlines.
Job Title
Assistant Manager - Production | Pharmaceuticals | Madurai