About this role
Description:
This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical ingredients and finished products within a regulated manufacturing environment. The position operates and monitors capsulation equipment and related manufacturing apparatus to support solid dosage form production objectives. It involves the careful handling of raw materials as well as intermediate and finished pharmaceutical products to maintain product integrity and quality. The role contributes to the filling and assembly of capsule dosage forms in accordance with established formulations and batch manufacturing records. General maintenance activities on capsulation machines, blenders, and related machinery are performed as required to ensure operational continuity. All activities are executed in strict adherence to Standard Operating Procedures and current Good Manufacturing Practices to meet regulatory requirements. Accurate and timely completion of batch records and manufacturing documentation is maintained as a core accountability. The position participates in process improvement initiatives aimed at enhancing quality, reducing costs, and optimizing production scheduling within the capsulation function.
Essential Functions:
- Operate and monitor capsulation equipment and related manufacturing apparatus in accordance with validated procedures and GMP standards
- Handle raw materials, intermediate products, and finished capsule goods with care to maintain product quality and prevent cross-contamination
- Perform capsule filling and assembly operations for solid dosage forms per approved batch manufacturing records
- Mix and blend ingredients for capsule powders and granulations per approved formulations as required
- Conduct general maintenance on capsulation machines, blenders, and related equipment to ensure operational readiness
- Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements
- Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines
- Participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling
- Support area cleaning and sanitization activities to maintain a compliant and safe manufacturing environment
Additional Responsibilities:
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses: