Job Description
Ensure in-process controls are performed as per specifications.
Coordinate with QA/QC for sampling, analysis, line clearance, and batch release.
Raise and investigate deviations, OOS, OOT, CAPA, and Change Controls.
Ensure Right First Time (RFT) manufacturing
Ensure accurate and timely completion of:
Batch Manufacturing Records (BMR)
Equipment Logbooks
Cleaning Records
Calibration Records
Usage Logs
Shift Reports
Maintain compliance with cGMP, GDP, Data Integrity, SOPs, and regulatory guidelines.
Participate in regulatory and customer audits
