Kitty Raina

Background

About Kitty Raina

Hands on experience of Vendor Qualification of Raw Material and Primary Packaging Material. • Alternate Vendor Development for Existing Materials. • Specification Comparison, Technical Document Review and compliance of Vendor Documents as per Organization requirements. • Conducting Onsite Audit of Raw Materials and Printed Packaging Materials. • Verification and closure of Compliance Report of Onsite Audits. • Desktop Audit Evaluation of vendors. • CAPA and compliance closure for any rejection of materials. • Preparation and Updation of Approved Vendor List for RM and PM. • MPN maintenance of vendors in SAP • Preparation of Corporate Quality Assurance SOP’s. • Coordination with various Loan License Manufacturing plants for Vendor related issues. • Set up of Corporate Quality Assurance Department for the required activities and SOPs. • Coordination with all manufacturing plants (3. No’s) for Vendor Documents. • Core team member of Quality Assurance, handling of Quality Management Systems like Change control, Deviation, Market complaints, Corrective and Preventive action (CAPA) etc. • Ensure compliance to cGMP for all operational activities for Tablets, Capsules and Dry Syrups. • Provide appropriate training and development to the colleagues. • Dosage forms handled: Tablets, capsules, dry syrup. • Prepared & participated in regulatory audits (ANVISA, MCC, TGA & Health Authority Inspections). • Conducting the in process quality checks viz line clearance, calibrations, validations, sampling, in-process checks for tablets, capsules, dry syrups. • Online review of batch records & related documentation for release of batches to market. • To prepare and review Quality Assurance SOP’s. • Run reports in electronic system to ensure that all requirements related to batch release are met. • Review Master Formula (Manufacturing/Packing Instruction) and SOP’s. • Ensure Stability Samples are collected and charged without any miss. • Handling and Calibration of IPQA Instruments like Friability Apparatus, Disintegration Tester, Hardness Tester and Balance etc. • All time readiness for Quality compliance including In-process and Quality management system in a fully automated, multi-dosage formulation plant. • An outstanding member for In-process quality assurance compliance for multi-dosage formulation block. • All Time Readiness for fulfillment of Consent Decree requirement (CD – US DOJ). • Exposure to develop environment for compliance and working with USFDA consultants since Jan 2012.