Elanchselvam S

• Company Overview: AFRICA-CONGO, KINSHASA
• AFRICA-CONGO, KINSHASA

..................................................................................................................................................

WORK EXPERIENCE

• IPQA Activities
• To monitor routine manufacturing and packing activities and to ensure compliance to the systems and procedures as per cGMP
• To Monitor warehouse activities and ensure compliance to the systems and procedures as per cGMP
• Collection of process validation and hold time studies samples
• Preparation and review of Annual product quality review
• Co-ordinate with Equipment/instrument qualification team in shop floor
• In-process checks such as weight variation, disintegration, LOD, friability, hardness, and package integrity.
• Line clearance for manufacturing, packing, sampling and dispensing
• Sampling of Raw & Packing materials
• Review of Batch Manufacturing records, Batch Packaging records
• Handled line clearance for production activity
• Handled line clearance for the raw material and packaging material dispensing activity
• Handled in-process material sampling including blend uniformity sample
• Handled in-process material analysis and QA start-up
• Handling of reserve sample
• Dispatch of Finished goods
• Online Documentation of BMR/BPR & Log books
• Monitoring of PMP schedule
• Review of BMR and BPR
• Sampling of In-process/Finished product/Stability/Process validation samplesControl sample: Periodic visual inspection
• (Every month)
• Loading and retrieval of API, excipients, Primary Packing materials, Finished Drug products
• Preparation and maintaining of reserve sample calendar
• Issue and control of samples like API, Drug products, Excipients & Primary Packing materials