Description

JOB 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 sterile manufacturing environment, with a specific focus on injectable dosage form production. The position operates manufacturing equipment used in the production of injectable pharmaceutical products including filling machines, autoclaves, and filtration apparatus. It handles raw materials and intermediate or finished sterile products in accordance with established aseptic procedures and quality standards. The role supports the preparation and processing of injectable formulations including solutions, suspensions, and emulsions to meet product specifications. It performs general maintenance as required on manufacturing equipment to ensure operational continuity in a sterile environment. Standard operating procedures are executed to meet current Good Manufacturing Practices and all associated documentation requirements are maintained accurately. The position ensures full compliance with regulatory requirements including FDA and EMA guidelines applicable to sterile pharmaceutical manufacturing. It actively participates in program or functional team projects aimed at developing process improvement methods and solutions to enhance quality, cost efficiency, and scheduling outcomes.

Essential Functions

Operate manufacturing equipment for injectable pharmaceutical production including filling machines, autoclaves, and filtration apparatus in compliance with established SOPs
Handle raw materials and intermediate sterile pharmaceutical products with accuracy and strict adherence to aseptic technique and safety protocols
Support preparation and processing of injectable formulations including solutions, suspensions, and emulsions to meet product specifications
Perform general maintenance on manufacturing equipment as required to ensure operational readiness in a sterile environment
Execute standard operating procedures to meet current Good Manufacturing Practices (cGMP) requirements for sterile manufacturing
Maintain accurate batch documentation records in compliance with regulatory and internal requirements
Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines
Participate in process improvement projects to enhance quality, cost efficiency, and production scheduling
Conduct area cleaning and sanitization activities in accordance with cleanroom and aseptic GMP standards

Additional Responsibilities

QUALIFICATIONS

Education

Undergraduate HSC - Required
Diploma DBM - Preferred

Experience:

2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

Associate, Manufacturing Injectables