Description:
The role is responsible for executing coating operations under cGMP (current Positive Manufacturing Practices) conditions within the pharmaceutical manufacturing environment. The role supports safe, compliant, and efficient processing of oral solid dosage (OSD) products, ensuring adherence to approved Batch Manufacturing Records (BMR - Batch Manufacturing Record) and Standard Operating Procedures (SOPs - Standard Operating Procedures). The role operates coating equipment, performs in-process checks, maintains accurate documentation, and ensures environmental, safety, and quality compliance during batch execution. The role contributes to product quality, yield optimization, contamination prevention, and regulatory compliance, while supporting continuous improvement initiatives and maintaining online documentation systems as required by regulatory standards.
Essential Functions:
- Operate coating equipment in accordance with approved BMR (Batch Manufacturing Record) and SOPs (Standard Operating Procedures)
- Perform in-process checks (IPC - In-Process Control)
during coating operations & maintain E-logbook to ensure batch compliance
- Monitor coating parameters such as spray rate, inlet air temperature, atomization, and pan speed
- Maintain cGMP (current Valuable Manufacturing Practices) compliance during manufacturing operations
- Record batch data accurately in BMR & BPR (Batch Production Record) and online systems
- Ensure cross-contamination prevention through proper line clearance and cleaning practices
- Follow change room gowning techniques and cleanroom behavioral practices
- Support equipment cleaning & maintenance as per approved procedures
- Identify and report deviations, abnormalities, or equipment issues promptly
- Adhere to Environmental, Health & Safety (EHS - Environmental, Health & Safety) guidelines
- Participate in training programs and continuous improvement initiatives
Support audit readiness by maintaining documentation integrity and trac