About this role
1. IPQA / Shop Floor Activities
Perform In-Process Quality Assurance (IPQA) activities in production and packing areas.
Verify line clearance before commencement of manufacturing and packing operations.
Ensure compliance with approved BMR/BPR, SOPs, specifications, and process parameters.
Monitor critical manufacturing and packing activities and perform required in-process checks.
Verify equipment and area status before and during operations.
Ensure proper identification and status labeling of materials, products, and equipment.
Monitor compliance with GMP, hygiene, gowning, and housekeeping requirements.
Report and document any deviation, incident, or non-compliance observed on the shop floor.
2. Batch Documentation
Review manufacturing and packing records for completeness and compliance.
Verify entries for accuracy, traceability, and data integrity.
Ensure corrections in GMP documents are made as per approved procedures.
Review equipment and area logbooks as applicable.
Support batch record review and compilation for QA disposition.
3. Deviation, CAPA & Change Control
Initiate and support investigation of deviations, incidents, and non-conformances.
Assist in root-cause analysis and evaluation of impact.
Support preparation, implementation, and monitoring of CAPA.
Review and monitor change-control activities related to manufacturing and quality systems.
Track assigned quality-system actions for timely closure.
4. Sampling & In-Process Checks
Perform or coordinate in-process sampling and checks as per approved procedures.
Coordinate with QC for testing of in-process, bulk, and finished-product samples.
Ensure appropriate status identification and segregation of materials/products.
5. GMP & Compliance
Ensure compliance with cGMP, GDP, data integrity, SOPs, and applicable regulatory requirements.
Conduct routine GMP observations and report gaps to the concerned department.
Support implementation of corrective actions arising from audits and inspections.
Participate in internal audits, self-inspections, customer audits, and regulatory inspections.