Job Description

This role is responsible for performing a diverse range of manufacturing operations related to the processing and assembly of injectable pharmaceutical products within a regulated manufacturing environment. The position operates and monitors general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus to support injectable product manufacturing. It handles raw materials and intermediate or finished injectable pharmaceutical products in compliance with established procedures and aseptic processing standards. The role ensures that all manufacturing activities are conducted in strict adherence to current Good Manufacturing Practices and applicable regulatory requirements including FDA and EMA standards. It contributes to the preparation of injectable dosage forms through precise mixing, compounding, and filling operations. The position performs area cleaning and sanitization activities to maintain cleanroom and aseptic manufacturing area compliance standards. Accurate and timely completion of batch documentation and manufacturing records is a core accountability of this role. It participates in process improvement initiatives and functional team projects aimed at enhancing injectable manufacturing quality, cost efficiency, and production scheduling. The role operates within a highly regulated pharmaceutical environment, ensuring all injectable products meet defined quality and compliance standards.

Essential Functions:

• Operate and monitor general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus in the injectable manufacturing area.

• Handle raw materials, intermediate products, and finished injectable pharmaceutical goods in accordance with established SOPs and aseptic processing guidelines.

• Perform mixing, compounding, and filling operations for injectable pharmaceutical dosage forms in compliance with validated procedures.

• Perform area cleaning and sanitization activities to maintain cleanroom and aseptic manufacturing area compliance standards.

• Maintain accurate and complete batch documentation records including batch manufacturing records and equipment usage logs.

• Ensure all injectable manufacturing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements including FDA and EMA guidelines.

• Monitor manufacturing process parameters and equipment performance, identifying and escalating deviations as required.

• Participate in process improvement projects and functional team initiatives to enhance quality, reduce costs, and optimize production scheduling.

• Support general maintenance activities on injectable manufacturing equipment as required to ensure operational readiness.

Additional Responsibilities: Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: