Description:
This role is responsible for performing a variety of tasks related to the processing and assembly of ingredients and pharmaceutical products within a regulated manufacturing environment. The incumbent operates granulation equipment and related general manufacturing machinery including autoclaves, ovens, stills, and filtration apparatus to support solid dosage form production. The role handles raw materials and intermediate or finished products in compliance with stringent quality and safety standards. It involves executing standard operating procedures to meet current Good Manufacturing Practices and maintaining accurate records as required by regulatory bodies. The position ensures all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines. The role mixes and blends compound ingredients for tablet granulations and capsule powders to achieve the required product specifications. It supports the optimization of resource utilization while minimizing costs and maintaining the highest quality standards in pharmaceutical production. The incumbent plays a key role in sustaining a compliant and efficient granulation manufacturing operation within a global pharmaceutical organization.
Essential Functions:
- Operate granulation equipment and related manufacturing machinery including autoclaves, ovens, stills, and filtration apparatus in accordance with approved procedures
- Mix and blend compound ingredients for tablet granulations and capsule powders to meet product specifications
- Handle raw materials, intermediate products, and finished pharmaceutical goods with appropriate care and documentation
- Execute standard operating procedures to ensure compliance with current Good Manufacturing Practices at all times
- Maintain accurate batch documentation records and production logs as required by regulatory and quality standards
- Perform general maintenance tasks on granulation equipment, blenders, and other production machinery as needed
- Conduct area cleaning and sanitization activities to maintain manufacturing area standards
- Ensure all production activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines
Participate in functional team projects focused on developing process improvement methods, solutions, and procedures to enhance quality and scheduling
Additional Responsibilities:
