The IPQA Officer is responsible for ensuring that manufacturing and packaging activities are carried out in compliance with approved procedures, Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards.
The role involves monitoring production processes, conducting in-process checks, reviewing manufacturing documentation, identifying deviations, and ensuring that appropriate corrective actions are implemented to maintain product quality and patient safety.
Key Responsibilities
In-Process Quality Monitoring:
Monitor manufacturing and packaging activities to ensure compliance with approved SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and GMP requirements.
Perform routine in-process checks at various stages of production.
Verify critical process parameters and ensure they remain within approved specifications.
Inspect production areas, equipment, materials, and personnel practices for compliance with GMP.
Ensure proper line clearance is conducted before and after production activities.
Batch Documentation:
Review BMRs, BPRs, logbooks, checklists, and other production-related documents for completeness and accuracy.
Ensure all entries are made correctly, contemporaneously, and in accordance with Good
GMP Compliance:
Ensure production activities comply with current GMP requirements and internal quality standards.
Conduct routine GMP inspections of production and packaging areas.
Monitor personnel hygiene, gowning, material handling, cleaning practices, and environmental conditions.
Line Clearance and Area Inspection:
Conduct and document line clearance before commencement of manufacturing and packaging operations.
Verify removal of previous product, materials, labels, documents, and waste from production lines.
Inspect equipment and production areas to confirm readiness for the next batch.
Ensure proper cleaning and status identification of equipment and areas.
Educational Qualifications
Bachelor's degree in chemistry, Biochemistry, Microbiology, or a related Science discipline.
A professional qualification or relevant training in Quality Assurance/GMP is an added advantage.
Experience:
Minimum of 3 - 5 years of relevant experience in Quality Assurance, IPQA, Quality Control, or pharmaceutical manufacturing.
Experience in a pharmaceutical manufacturing environment is strongly preferred.
Practical knowledge of GMP, GDP, SOPs, deviation management, CAPA, change control, and batch documentation.