The Executive / Sr. Officer IPQA is responsible for ensuring compliance with cGMP, SOPs, and regulatory requirements during Oral Solid Dosage (OSD) manufacturing operations. The role involves line clearance, in-process quality assurance (IPQA), documentation review, and monitoring manufacturing activities to ensure product quality and regulatory compliance.

Key Responsibilities

- Perform line clearance before the start of manufacturing and packing activities.
- Conduct IPQA checks during OSD manufacturing processes, including dispensing, granulation, blending, compression, coating, capsule filling, and packing.
- Verify equipment cleanliness, line setup, and product changeover activities.
- Ensure compliance with cGMP, GDP, SOPs, and data integrity requirements.
- Review Batch Manufacturing Records (BMR), logbooks, and manufacturing documentation.
- Perform stage-wise process verification and ensure adherence to approved procedures and specifications.




- Monitor environmental conditions and GMP practices in production areas.
- Ensure proper status labeling, material identification, and line clearance compliance.
- Report deviations, non-conformances, and quality issues, and support investigations, CAPA, and Change Control activities.
- Coordinate with Production, QC, Engineering, and Warehouse departments for quality compliance.
- Participate in internal, customer, and regulatory audits.
- Maintain IPQA records and prepare daily quality reports.

Required Skills

- Hands-on experience in IPQA and Line Clearance during OSD manufacturing.
- Robust knowledge of cGMP, GDP, SOPs, and pharmaceutical quality systems.
- Experience in reviewing BMR and manufacturing documentation.
- Knowledge of WHO-GMP, EU-GMP, MHRA, and USFDA regulatory requirements.
- Good communication, analytical, and documentation skills.
- Proficiency in MS Office.

📌 QA - IPQA (Gujarat)
🏢 BioMatrix Healthcare
📍 Gujarat