Description:
This role is responsible for supporting injectable manufacturing operations by executing processing, equipment operation, and aseptic production activities within a regulated sterile pharmaceutical environment. The role operates manufacturing equipment such as autoclaves, washing machines, sterilizers, filtration systems, mixing vessels, and filling-related equipment to ensure timely batch execution. The incumbent handles raw materials, components, intermediates, and finished injectable products in accordance with approved procedures, aseptic practices, and quality standards. It ensures accurate batch documentation, equipment cleanliness, and compliance with cGMP and global regulatory requirements. The role contributes to safe and efficient production, supports equipment upkeep, and participates in continuous improvement initiatives to enhance productivity, quality, and schedule adherence in injectable manufacturing operations.
Essential Functions:
- Operate manufacturing equipment such as autoclaves, sterilizers, filtration units, mixing vessels, washing machines, and filling support systems as per SOPs
- Execute injectable manufacturing activities including solution preparation, filtration, sterilization, filling support, and component handling as per batch records
- Handle raw materials, containers, closures, intermediates, and finished injectable products in compliance with aseptic and GMP standards
- Maintain accurate batch manufacturing records, equipment logbooks, and production documentation in line with GDP requirements
- Perform equipment cleaning, sanitization, line clearance, and basic maintenance as per approved procedures
- Ensure compliance with cGMP, aseptic practices, safety guidelines, and regulatory requirements including FDA and EMA standards
- Support environmental control practices and maintain cleanliness of general and classified manufacturing areas
- Identify and report deviations, equipment malfunctions, or process abnormalities to supervisors promptly
- Participate in in-process checks and sampling activities to support product quality and batch release requirements
Contribute to process improvement initiatives focused on productivity, quality enhancement, cost control, and schedule adherence
Additional Responsibilities:
