Senior Assistant, Manufacturing Injectables

Description

JOB DESCRIPTION

This role is responsible for performing a variety of tasks related to the processing and assembly of injectable pharmaceutical products within a regulated manufacturing environment at a senior assistant level. The incumbent operates general manufacturing equipment for injectable production including autoclaves, ovens, stills, and filtration apparatus to support sterile injectable product manufacturing. The role handles raw materials and intermediate or finished injectable 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 contributes to process improvement initiatives by participating in functional team projects aimed at enhancing quality, cost efficiency, and scheduling effectiveness. It supports the optimization of resource utilization while minimizing costs and maintaining the highest quality standards in sterile pharmaceutical production. The incumbent plays a key role in sustaining a compliant and efficient injectable manufacturing operation within a global pharmaceutical organization.

Essential Functions

• Operate manufacturing equipment for injectable production including autoclaves, ovens, stills, and filtration apparatus in accordance with approved procedures.
• Handle raw materials, intermediate products, and finished injectable pharmaceutical goods with appropriate care and documentation.
• Execute standard operating procedures to ensure compliance with current Good Manufacturing Practices for sterile manufacturing.
• Maintain accurate batch documentation records and production logs as required by regulatory and quality standards.
• Perform general maintenance tasks on pumps, homogenizers, filter presses, and other injectable production equipment as needed.
• Conduct area cleaning and sanitization activities to maintain cleanroom and sterile manufacturing area standards.
• Ensure all production activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines for injectables.
• Monitor production process parameters and report any deviations or non-conformances to supervisors promptly.
• Participate in functional team projects focused on developing process improvement methods, solutions, and procedures to enhance quality and scheduling.
  
  

Additional Responsibilities

QUALIFICATIONS

Education

• Undergraduate HSC - Required
• Undergraduate ITI - Preferred
• Undergraduate Diploma-Preferred
  
  

Experience

• 2 years or more in 2 - 5 Years
  
  

Specialized Knowledge: Licenses: