MITUL DESAI

More than 8 year of experience in Quality Assurance (QA) Department in different area like Qualification and Validation, In-process Quality Assurance, Quality Management System, Quality Specialist in FDA regulated Pharmaceutical, Bio-Pharmaceutical Industry.

QUALIFICATION AND VALIDATION:

• Design, review and execute validation document activities such as URS, Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria.
• Prepare, execute and review of re-qualification document of equipment, facility and utilities
• Identification of deviation through review and observation.
• Co-ordinate with production, other user department and external agencies for qualification/validation activities.
• Timely compile and review of qualification reports.
• Execution and review of facility qualification documents, Facility URS for new green field projects.
• To prepare annual Re-qualification schedule, update VMP and Qualification related SOP's as and when required.
• Execution / Review of Initial qualification (Development and Performance Qualification) and Requalification of Isolator (HEPA Validation & VHP cycle qualification), HVAC, SIP / CIP validation (Manufacturing vessel, filtration vessel, Liquid and Dry powder vial filling machine), Vial Washing, Depyrogenation Tunnel, Filling machine, External Vial Washing Machine, Terminal Sterilizer, Autoclave Load Validation, Leak test validation.
• Execution of initial qualification & Periodic qualification of HEPA Mounted equipments (Bio safety cabinet, Dynamic Passbox, laminar Air flow unit, Containment Isolator.
• Execution of Pure Steam Qualification, Compressed Air Qualification.
• Execution(IQ, OQ, PQ) of Water System Qualification (Purified water& WFI).
• Execution of Temperature mapping study of Cold Room, Cold Cabinet, Incubators , Deep Freezers, Ultra Low Temperature Freezer and Temperature / %RH controlled area.
• To prepare, execution and review of the process Validation, Cleaning verification protocols and reports.
• BMR execution all process validation activities.

INPROCESS QUALITY ASSURANCE, QUALITY MANAGEMENT SYSTEM AND COMPLIANCE

• Writes, reviews and revises SOPs as directed by QA Manager/Director.
• Conducts internal audits for compliance with SOP, cGMP & FDA requirements.
• Scheduling and coordinating daily priorities for incoming raw material, in-process material, finished product and in-process packaging/labeling operations sampling and inspection activities
• Trains, supervises and evaluates the performance of QA Team to assure compliance with Standard Operating Procedures (SOPs)/cGMP.
• Final product: Monitors all stages of QA in-process/packaging operations to ensure strict compliance with cGMP/SOPs.
• Handles Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPA) through effective quality management tools.
• Monitors and ensures that batch records are audited per manufacturing/packaging/shipping requirements,when required.
• Prepared and Reviewed the Annual Product Quality Review (APQR) and Batch Record (BMR & BPR).
• Development and implementation of Internal Quality Audit and External Audit, Regulatory Audit Faced: USFDA, MHRA, ANVISA, MCC, TGA, Pre-Approval Inspections and
• Document Review, and Identify Gap in Quality System.
• Collaborated with cross-functional teams to develop and implement strategies to improve data quality and ensure data integrity is in compliance with cGMP and GDP requirements.
• Supported manufacturing QA Activities, In-Process Quality checks, Enhancing Sterility Assurance Levels.