Swapnil Ghanwat
CSV Professional
Ambernath
Summary
Dedicated and results-oriented Computer System Validation Lead with over 14 years of experience in the pharmaceutical industry. Proven track record of successfully leading validation projects, ensuring compliance with regulatory standards such as FDA, EMA, and GMP. Proficient in developing validation strategies, managing validation teams, and implementing quality systems. Strong expertise in validation protocols, risk assessments, and documentation practices.
Overview
14
14
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Assistant Manager CQA
Alkem laboratories Ltd.
5 2022 - Current
- Led a team of validation specialists in planning and executing computer system validation activities for critical systems used in pharmaceutical manufacturing and quality control
- Authored and reviewed validation deliverables like HLRA, SRS, VP/QP, FS, CS, DS, DQ, IQ, OQ/FTS, PQ, UAT, RTM, VSR etc
- Developed and implemented validation strategies, protocols, and procedures in compliance with regulatory requirements
- Conducted risk assessments and gap analyses to identify areas for improvement and ensure the integrity of validated systems
- Collaborated with cross-functional teams including IT, Quality Assurance, and Regulatory Affairs to ensure alignment of validation activities with business objectives
- Managed vendor relationships and third-party consultants to support validation efforts and resolve technical issues
- Provided training and guidance to team members on validation best practices and regulatory requirements
- Audit & Compliance of contract manufacturing sites like OSD, Semisolid and liquid preparation
- Handling of Quality management system i.e
- Change controls, Deviations, CAPA reports, Incident and investigation reports, OOS (Out of Specification) of sites
- Monitoring, evaluation and effectiveness checking of CAPA which derived from investigation and audits
- Handling of Market complaints investigation.
Assistant Manager Quality Control
Dishman carbogen amcis Ltd.
01.2021 - 04.2022
- Executed validation protocols for equipment, software, and processes in accordance with company policies and regulatory guidelines
- Performed periodic reviews and revalidation activities to maintain the validated state of systems throughout their lifecycle
- Supported regulatory inspections and audits by preparing documentation and responding to inquiries related to validation activities
- Leading Quality Management System
- Performing Gap – Assessment and inline the SOP as per current Gxp Requirements and pharmacopeial update
- Investigation of Deviations, OOS and laboratory incident
- Performing CSV validation of new laboratory instruments
- Performing Periodic review of standalone system audit trail, Databackup, Data restoration activity
- Conducting Awareness Training of Data Integrity, GDP
- Planning GC section and timely release raw material, in process, intermediate and finish product.
Team Leader Quality Control
Solara Active Pharma Sciences .Ltd
06.2019 - 01.2021
- Implemented improvements to validation procedures and documentation to enhance efficiency and compliance
- Participated in cross-functional teams to assess the impact of system changes and ensure validation requirements were addressed
- Leading Non-Routine section
- Logging and managing the investigations for deviations, OOS, Market complaint and providing CAPA implementation for the same through Trackwise
- SOP Revision & implementation
- Handling Instrumentation (Non Routine) section
- Performing CSV validation and compliance expertise within Software Validation activities in GxP regulated environments
- Managing the validation of new systems as well as changes to existing systems of the laboratory in E-Compliance role.
Executive Quality Control
Sandoz Pvt. Ltd.
04.2013 - 06.2019
- Conducted validation testing, including IQ/OQ/PQ, for laboratory instruments, manufacturing equipment, and software applications
- Reviewed and approved validation documentation such as validation plans, protocols, reports, and standard operating procedures (SOPs)
- Investigated and resolved validation discrepancies and deviations in a timely manner to maintain project timelines
- Provided technical support to end-users and IT personnel regarding validation requirements and system functionality
- Performing CSV validation and compliance expertise within Software Validation activities in GxP regulated environments
- Managing the validation of new systems as well as changes to existing systems of the laboratory in E-Compliance role
- Facilitating compliance to all quality management systems, reporting OOS, OOC identifying root causes and effectively implementing corrective measures in order to prevent their re-occurrence
- Logging and managing the investigations for deviations, OOS, Market complaint and providing CAPA implementation for the same
- Conducting breakdown investigation & investigation of Chromatographic error and documenting such investigations including actions taken
- Imparting training to executives on various instruments, analytical methods and safety measures; creating an environment that sustains & encourages high performance
- Preparing protocol, experimental designs, test data sheet and summary of validation data.
Officer
Cipla Limited
09.2011 - 03.2013
- Analysis In-process and process validation samples of API
- Method Transfer for API and Drug Product from AR&D to QC Lab
- Validation of analytical test procedures for API and Drug Product
- Supporting for Investigation of OOS, OOT, Incidents and Market complaints for the Drug Products
- Implement the changes such as containers to carry out the tablets, trays to carry the blend uniformity bottles to enhanced the productivity, quality & safety.
Officer
Agio Pharmaceutical Limited
10.2010 - 09.2011
- Analysis Finished Product like Tablet, Capsule, Ointment, Injection
- Performing Calibration of Instrument
- Supporting for Investigation of OOS, OOT, Incidents and Market complaints for the Drug Products.
Education
M.Sc. - Analytical Chemistry
T.C. College Baramati, University of Pune
Pune 06.2008 - 06.2010
B.Sc. - Chemistry
T.C. College Baramati, University of Pune
Pune 06.2005 - 06.2008
Skills
Quality Management System
Equipment Qualification
Lab Instrument Qualification
Computer System Validation
Risk Management
Change & Configuration Management
Quality Inspection
CSV Validation
SDLC
21 CFR Part 11
Agile and “V” Model
Laboratory software: Trackwise, SAP, Labx, TOC Control L, Tiamo, SpectraManager, Chromeleon, Enviro, ICDAS, Chemstation
Instruments Used
- HPLC (Make: Agilent, Shimadzu, Thermofisher)
- UHPLC (Make: Agilent)
- UV Spectrophotometer (Make: Shimadzu)
- FTIR Spectrophotometer (Make: Perkin Elmer)
- Dissolution (Make: Electro lab)
- KF-Autotitrator, pH meter, Conductivity-meter, Potentiometer (Make: Metrohm)
- Friability Test Apparatus (Make: Electro lab)
- Tapped Density Apparatus (Make: Rankle)
- Viscometer (Make: Brookfield)
- GC (Make: Agilent, 6890N & 7890A)
- TOC Analyzer (Make: Shimadzu)
Personal Information
Date of Birth: 08/01/88
Timeline
Assistant Manager Quality Control
Dishman carbogen amcis Ltd.
01.2021 - 04.2022
Team Leader Quality Control
Solara Active Pharma Sciences .Ltd
06.2019 - 01.2021
Executive Quality Control
Sandoz Pvt. Ltd.
04.2013 - 06.2019
Officer
Cipla Limited
09.2011 - 03.2013
Officer
Agio Pharmaceutical Limited
10.2010 - 09.2011
M.Sc. - Analytical Chemistry
T.C. College Baramati, University of Pune
06.2008 - 06.2010
B.Sc. - Chemistry
T.C. College Baramati, University of Pune
06.2005 - 06.2008
Assistant Manager CQA
Alkem laboratories Ltd.
5 2022 - Current