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 manufacturing environment. The job role is responsible for executing and supervising manufacturing activities for sterile injectable products (liquid or lyophilized), ensuring compliance with aseptic practices, regulatory requirements, and quality standards. The incumbent operates general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus to support production activities. Raw materials, intermediate products, and finished goods are handled in accordance with established procedures and safety standards. Compound ingredients are mixed for liquid products, suspensions, ointments, tablet granulations, and capsule powders to meet formulation specifications. General maintenance activities are performed on equipment such as pumps, homogenizers, filter presses, and tablet compression machines as required. Standard operating procedures are followed to meet current Good Manufacturing Practices and all applicable regulatory requirements. Accurate and complete manufacturing records are maintained in compliance with documentation standards. The role contributes to process improvement initiatives aimed at enhancing quality, reducing costs, and optimizing production scheduling within the pharmaceutical manufacturing function.
Essential Functions
- Perform processing and assembly tasks related to pharmaceutical ingredients and finished products in compliance with GMP standards.
- Operate general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus as per standard operating procedures.
- Handle raw materials, intermediate products, and finished goods with accuracy and adherence to safety and quality protocols.
- Operate and monitor injectable manufacturing equipment (e.g. Autoclave, vial filling, ampoule filling, isolator, lyophilizer, compounding vessels).
- Execute batch manufacturing activities as per BMR/BPR & ensure line clearance before and after operations.
- Perform filtration, compounding, aseptic operations as per SOP.
- Execute standard operating procedures to meet current Good Manufacturing Practices and maintain all required manufacturing records.
- Ensure all tasks are completed in compliance with regulatory requirements including FDA and EMA guidelines.
- Participate in program or functional team projects to develop process improvement methods, solutions, and procedures.
- Support enhancement of program quality, cost efficiency, and production scheduling through active team participation.
Additional Responsibilities
QUALIFICATIONS
Education
- Diploma DBM - Required
- Bachelors Degree (BA/BS) B. Sc. - Preferred
Experience:
- 2 years or more in 2 - 5 Years
Specialized Knowledge: Licenses: