Nitin Patil

• Working with clients for resource management, resource onboarding, SOW creation and follow ups, SOW renewal etc.
• Participated in various firm building initiatives like creating service offerings, RFPs etc.
• Responsible for corporate recruitment and interviews of TCS associates and new joiners to the team.
• Awareness creation among project teams for applicable compliance areas.
• Software validation in Agile environments, developing continuous validation strategies for frequent software updates.
• CSV initiatives for cloud-based and on premise GxP systems, ensuring compliance with FDA, EMA MHRA, and other global regulations.
• Performed vendor qualification and audits, ensuring third-party software solutions meet regulatory expectations.
• Authoring deliverables as per the solution profiling starting from Validation Plan to Validation Summary.
• Hands on experience to create the Requirements in JIRA.
• Hands on experience to create Test Cases with respective Test Steps in qTest.
• Experience in authoring Validation deliverables, Requirements gathering, Test Script creation, formal execution, defect management etc.
• Guidance and Consultation in Scrum calls for Validation, Compliance parameters RFC/Change Management Process, Deviation, CAPA management etc.
• Expertise in leading and handling a team, onsite-offshore co-ordination, task allocation and tracking, process compliance, strong problem solving and delivering results within the desired timelines.
• Periodic Review of compliance status of IT applications as per the organizational guidelines and follow-ups with stakeholders on related compliance.
• Tracking and Guidance for meeting Compliance Requirements (CRS).
• Review and Approval of SDLC and Validation related project documentation (Plan till deployment).
• Providing Quality consultancy with specific exposure to GxP, GAMP 5, SOX, 21CFR Part 11, and ERES etc.
• Preparation of Weekly Summary Report and publishing to the customer.

• Have thorough understanding and practical approach for Computer System Validation.
• Compliance of CSV documentation during various phases of SDLC.
• Aware with GAMP-5, CFR Part 11/ EU Annex 11 and Data Integrity requirements.
• Verification of existing application software for compliance of 21 CFR Part 11/EU Annex 11 to determine possible quality risks associated with it.
• Review of Validation Plan, Training Plan, IQ OQ and PQ Protocols and Validation Protocol.
• To guide and train IT and CSV teams for CSV, Data Integrity and Regulatory Compliance activities.
• Review of QMS documents e.g. Change Control/Deviation/CAPA/User Access forms etc.
• Auto and manual data backup for computerized and automated systems.

• Wholly participation in qualification activities in green field project to qualify different types of equipment along with their software to comply with 21CFR Part11 and GAMP.
• Exposure to GDP, GMP, FMEA, GAMP-5, Software Categorization, Calibration Management etc.
• Supporting in the auto data backup and manual data backup for computerized and automated systems of all manufacturing equipment.
• Review of Validation Plan, Training Plan, IOQ Protocol/ Report, PQ Protocol/ Report and Validation Protocol/ reports.
• Perform compliance review of all QMS documents related to Change Control, Deviation, OOS, CAPA, writing technical documents for Investigation Report and Impact Assessment etc and manage all closure efforts.
• Verification of Audit Trails and Data Reports of BMS system, Water Equipment, Utility Equipment on routine basis as per predefined frequency.
• Handling of technical change control, deviation and investigation management through quality management system.
• Review of CSV deliverables like Validation Project Plan, URS, VP, DS, FS, TM, IQ, OQ, PQ, Computer System Risk Assessment, Periodic Review Report, SOP etc.
• Co-ordinate with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems, system suitability tests, and resolving technical issues.
• Mentoring and leading CSV Team members and providing technical guidance as necessary during verification and validation activities.

Participate in project meetings to ensure timely completion of ongoing projects.

• To ensure GEP and GMP in all new incoming projects and modifications of existing equipment, areas, facilities.
• Participation in all FAT and SAT activities to guide team for execution of test cases, handling deviations/ defects occurred during testing.
• Handled technical change control, deviation and investigation management through quality management system.
• Coordinated with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems, and resolving technical issues.
• Exhibits excellence in reviewing various engineering drawings & documents like control philosophy, instruments list, P & ID, Logic Diagrams and instrument loop drawings, Hook-up drawings, valve matrix, schematic drawings, Wiring Diagrams and Control schematics, alarm occurrence reports, service reports, calibration certificates etc.
• To ensure all planned and unplanned maintenance activity and its impact on Equipment/ System/ Area.
• Abundant experience in generating and reviewing Computer Systems Validations CSV deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries.
• Good experience in Gap Analysis and documenting Remediation Plan.
• Support for preparation of Site Master File (SMF).
• Supported to create, revise, and update control system SOPs in support of protocols, computer system changes, and departmental operations.
• Internal auditing for Engineering Compliance.
• Working closely with cross-functional project team for execution of qualification/ validation of equipment like autoclaves and utilities like HVAC, BMS, PLC, DCS, SCADA, HMI, purified water system and associated control systems.
• Perform GAP analysis, Risk Assessment using FMEA model, implement Quality Risk Management Systems to define qualification/validation strategy, prepare risk scenario and RPN evaluation, identifies critical control points, determine degree of testing required, define test procedure and acceptance criteria on the basis of current controls verified from functional and design specification submitted by manufacturer.

• Expertise in validation of the Critical utilities like Purified water system, WFI, PSG, Nitrogen.
• Experience in HVAC installations and validations followed by periodic re-validations.
• Exposure in Temperature mapping activity of specific areas.
• Having very good knowledge in preparing SOPs and exposure in review and approval of equipment master list, PM and Calibration planners.
• Calibration document reviews and approvals.
• Process knowledge and experience in computerized system validation on quality systems, manufacturing equipment, IT quality systems, records management etc.
• Participation in FAT and SAT activities for execution of protocols, handling deviations occurred during testing.
• Supported to create, revise and update control system SOPs in support of protocols, computer system changes and departmental operations.

• Review of equipment/ system qualification documents like URS, FDS, SDS, HDS, IQ and OQ for equipment like Autoclave, TFF, Particle monitoring system, Data acquisition system, freezers, cold room, extraction systems, MCDP, WFI S & D and other portable and customized equipment.
• Experience in Equipment qualification, computer system validation using ‘V’ model- starting from URS review, perform Installation Qualification, Operational Qualification for equipment hardware and software like DAS, PLC, HMI, SCADA, Autoclave, Fermenter, Particle Monitoring System, Tunnel, Washer, TFF, BMS, MCDP, PW S & D, packing machines, externally developed process control applications etc.
• Preparation of Project Plan, performing FAT at supplier site etc.
• Responsible for Erection, commissioning and testing activities. Managing all in-house project related activities, installation and commissioning of PLC and PC aided systems linked with CIP, SIP, Autoclave, BMS, DAS and water systems.
• PLC and PC based system validation including verification of audit trails, database integrity, access levels, security levels, data archival and backup verification, I/O verification, set parameters verification etc.
• Periodic revalidation of PLC systems, Data Acquisition systems for verification of system integrity by challenging the system to verify its performance in abnormal conditions.
• QA oversight to Engineering Department to ensure that proper procedure has been followed while performing planned, unplanned maintenance, calibration etc.