31 Jul
|
BioMatrix Healthcare
|
Gujarat
31 Jul
BioMatrix Healthcare
Gujarat
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.
Valuable communication, analytical, and documentation skills.
Proficiency in MS Office.
📌 Qa Ipqa Gujarat
🏢 BioMatrix Healthcare
📍 Gujarat