• Sterility Test, Bioburden, LAL Test & record updating.
• Clean Room Environment Monitoring
• Pathogen testing of water.
• Coordination with QA HOD reg. training, OOS investigation, audit.
• Extend the support of regulatory affairs in preparing the analytical data as the requirement of product registration at different countries.
• Ensure compliance of cGMP practices & preparation of SOPs.
• Physical, chemical & microbiological testing of RM/PM/FP & in process sample.
• Media preparation, sterilization & testing & discard with documentation.
• Culture transfer.
• Microbiological testing of samples.
Angiplast is manufacturing Medical Devices since last 20 years having ISO 13485, CE certification of manufacturing Class 1 and Class 2 devices. Company is also registered with USFDA and has USFDA 510k for several Products. More than 75% of the production is exported. The company is growing at CAGR 20 % and has aggressive expansion plans.
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