IPQA Officer at Shalina Healthcare

Job Summary

• 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.