Executive, IPQA ( Amneal )
6/4/20261 min read
Roles and Responsibilities
Essential Functions:
Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations
Oversee calibration of IPQA instruments
Review of and release of Batch
Review the in-process and finished product COA before batch release
Keeping records & review of equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records
Execute Line Clearance and Readiness for manufacturing, packing, and dispensing areas
Conduct routine In-Process Checks and coordinate with IPQC (In-Process Quality Control)
Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)
Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy
Perform Environmental Monitoring and routine monitoring of manufacturing areas
Ensure assurance of cleaning, sterilization, and aseptic manipulations
Support Sampling of Cleaning Validation and record compilation
Assist in Process Validation Reports (PVR – Process Validation Report) activities
Support Aseptic Process Simulation (Media Fill) monitoring
Ensure Good Documentation Practices (GDP – Good Documentation Practices) compliance
Participate in Routine GMP Inspections and quality record reviews
Additional Responsibilities:Real-time Monitoring and Compliance Reporting.
Participation in Investigations.
Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.
Maintain IPQA-related documents and records in a state of audit readiness.
To have good written and verbal communication skills in English language.
Qualifications
Education:
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred
Experience:
1 year or more in 1 - 4 Years
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