Ajit Kumar Prusty

To a dedicated and detail-oriented IT CSV Analyst with a strong track record of ensuring compliance with FDA regulations and industry standards. Expert in developing protocols and documentation for computer systems used in the pharmaceutical industries. Proven ability to lead validation projects and teams to successful completion.

• I evaluate software in accordance with GAMP, 21 CFR part 11, EU Annex 11, CSV policies, and SOPs.
• I am responsible for the preparation and review of all levels of CSV validation documents, including IRS, URS, VP, RA, FCS, RTM, and VSR
• I have extensive experience in SDLC methodologies, like the V-model
• As part of high-level risk assessment (HLRA), I conducted GxP assessment, GAMP compliance, performed critical assessment, and ERES applicability to ensure continuous compliance of computerized systems
• I am responsible for software qualification, including reviewing IQ, OQ, and PQ documents and their reports as per SOPs. Additionally, I coordinate with cross-functional teams related to software, equipment, utilities, processes, etc.
• Preparation of the tracebility mattrix (TM), URS, FCS (Functional Configuration specification) and DCS (Design Configuration Specification) Documents.
• Preparations and reviewing of application evaluation documents, like User Access Review (UAR), Periodic Review (PR), and Data Integrity review (DI)
• I efficiently handled and prioritized incoming support tickets, ensuring timely resolution and excellent user satisfaction
• I specialized in developing validation protocols such as IQ, OQ, and PQ, and executing validation deliverables to ensure compliance and reliability
• I manage QMS documentation, which involves handling change controls, CAPA, and deviations; additionally, I review documents related to defect, deviation, and CAPA processes
• I am responsible for review of the protocols, reports, SOPs in DMS application.
• I have experience in CALIBER LIMS modules like Stability, EM, Inventory management, Lot management, Instrument management, and Sample management
• Extensive experience in the creation of LIMS master data, such as analysis, product, sampling point, item code, sample login, batch, and stock inventory
• Hands-on experience in instrument management (instrument registration, scheduling, interface communication), mapping of fields from LIMS master data to CDS system
• As part of the LIMS installation, verifying controlled approved documents versus the LIMS workflow Support quality control users by LIMS application and master data creation with GMP perspective, along with transactions
• Evaluation of QMS events, assessment process, and change control procedures for systems
• Supported the creation, implementation, and maintenance of the site CSV/Data Integrity compliance program, strategy, and provided the necessary training

• Caliber LIMS Validation
• Labware LIMS Validation
• Empower-3 Validation
• Lab Solutions CDS and Non-CDS Validation
• Open Lab Validation
• IT System Evaluation (URR, SPR)

• English
• Hindi
• Odia

• Date of Birth: 07/05/96
• Gender: Male
• Nationality: Indian
• Marital Status: Married

Riding, Travelling, Hiking, Photography

I do hereby declare that all the statements furnished in this Curriculum vitae are true to the best of my knowledge and I bear responsibility for the correctness of the above mention particulars.

Place: Hyderabad (TG)