Job Description
Description:
This role is responsible for performing a variety of tasks related to the compression and coating of pharmaceutical tablets within a regulated manufacturing environment. The incumbent operates tablet compression and coating equipment and related general manufacturing machinery to support solid dosage form production in compliance with stringent quality and regulatory standards. The role handles raw materials and intermediate or finished products in compliance with 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 mixes and blends compound ingredients for tablet granulations and applies coating processes to achieve the required product specifications. It supports the optimization of resource utilization while minimizing costs and maintaining the highest quality standards in pharmaceutical production. The incumbent plays a key role in sustaining a compliant and efficient compression and coating operation within a global pharmaceutical organization.
Essential Functions:
- Operate tablet compression and coating equipment and related manufacturing machinery in accordance with approved procedures and production schedules
- Handle raw materials, intermediate products, and finished pharmaceutical goods with appropriate care and documentation
- Execute standard operating procedures to ensure compliance with current Good Manufacturing Practices for compression and coating operations
- Maintain accurate batch documentation records and production logs as required by regulatory and quality standards
- Perform general maintenance tasks on compression machines, coating pans, and other production equipment as needed
- Conduct area cleaning and sanitization activities to maintain manufacturing area standards
- Ensure all production activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines
- Monitor compression and coating 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 :
- Comply with all applicable EHS policies, SOPs, statutory requirements, and use the prescribed PPE while performing assigned duties.
- Identify and promptly report unsafe acts, unsafe conditions, near misses, incidents, and environmental hazards, and support corrective and preventive actions.
- Actively participate in EHS training, emergency preparedness, risk assessment, and continuous improvement initiatives to promote a safe, healthy, and environmentally responsible workplace.
Education:
- B. Pharm - Required
- M. Pharm - Preferred
Experience:
- 2 years or more in 2 - 6 Years
Specialized Knowledge: Licenses: