QA-IPQA

QA-IPQA – Job Responsibilities

Experience Require 05 to 06 year

Note: Priority API Experience only

• Perform in-process quality assurance (IPQA) activities during API manufacturing operations.
• Monitor manufacturing processes and ensure compliance with BMR/BPR SOPs GMP and safety requirements.
• Verify line clearance equipment status cleaning status and material identification before processing.
• Monitor critical process parameters and in-process controls at defined stages.
• Review and verify manufacturing and packaging records for completeness and compliance.
• Report and support investigation of deviations OOS/OOT incidents and non-conformances.
• Ensure proper documentation and ALCOA data integrity practices.
• Coordinate with Production QC Warehouse Engineering and QA for quality-related activities.
• Support validation qualification change control CAPA and audit activities.
• Ensure compliance with applicable GMP and regulatory requirements throughout manufacturing.

Required Skills:

API manufacturing In-process quality assurance (IPQA) Manufacturing process monitoring BMR BPR SOPs GMP Safety requirements Line clearance verification Equipment status verification Cleaning status verification Material identification Critical process parameters monitoring In-process controls Manufacturing record review Packaging record review Deviation investigation OOS (Out of Specification) investigation OOT (Out of Trend) investigation Incident reporting Non-conformance reporting Documentation ALCOA data integrity Cross-departmental coordination Production Quality Control (QC) Warehouse management Engineering collaboration Quality Assurance coordination Validation Qualification Change control CAPA Audit activities Regulatory compliance