Rakesh Singh

Biography

Quality Assurance Executive Company Name Natco pharma limited Dates Employed Mar 2013 – Present Employment Duration 4 yrs 7 mos Location Dehradun uttrakhand  *Prepare and Review of Validation Master Plan.  *Preparation And Execution of Installation, Operational and Performance Qualification documents for all Equipments  *Validation of Heating Ventilation and air Conditioning System of Clean Rooms i.e Particle count(Viable & non viable), Air Change Calculation, Air flow Pattern etc.  *Water System Validation like Pretreatment Water, Purified water & Water for Injection i.e. Phase I, Phase II Phase III  *Review & execution of Protocol for Process Validation (Tablet, Capsule & Injection)  *Preparation of Hold Time Study protocol, execution and preparation of report  *Qualification of Equipments (Sterilization & Depyrogenating Tunnel, Autoclave cum Bung Processor, Ampoule &Vial Washing Machine, Ampoule &Vial Filling Machine, HLAF ,SIP&CIP System.  *Qualification of RLAF (Sampling and Dispensing Booth), PSG, Nitrogen &Compressed air.  *Process Simulation Study( Aseptic Media fill trials of filling lines).  *Auditing the production block for non compliance (Internal audits)  *Updating of Specifications (Raw/Packing material) in Document Management System (SAP)  *Review of documents (BPR, STP, Specification, QC Reports and SOPs).

Research Interest

Pharmaceutical Science