Vishal Balprakash Sawant
R&D Scientist
Goa,GA
Summary
Senior Quality & Analytical Science Leader with 15+ years of experience in Pharmaceutical Quality Control (QC), Computer System Validation (CSV), and Regulatory Compliance. Proven expertise in leading cross-functional teams, driving GMP compliance, and managing end-to-end analytical method validation and laboratory systems aligned with USFDA, MHRA, EU Annex 11, and CFR Part 11. Recognized for implementing data integrity (ALCOA+), risk-based validation (GAMP5), and continuous improvement initiatives that enhance quality systems, audit readiness, and operational efficiency.
Overview
15
15
years of professional experience
6
6
Certifications
1
1
Language
Work History
Research Scientist-II
Unichem Laboratories Ltd
08.2014 - Current
- Led Computer System Validation (CSV) lifecycle (IQ/OQ/PQ) for laboratory systems ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5
- Managed validation documentation including Validation Plans, Test Protocols, and Summary Reports
- Identified compliance gaps and implemented process improvements, enhancing audit readiness by 30%
- Led cross-functional teams for timely execution of validation and analytical projects
- Directed OOS/OOT/OOC investigations, risk assessments, and CAPA implementation
- Spearheaded data integrity initiatives aligned with ALCOA+ principles
- Developed and validated analytical methods for ICP-MS, LCMS, XRPD, DSC, TGA, RAMAN, NMR, and IR
- Supported regulatory submissions and successfully addressed DMF queries
- Conducted polymorphic and elemental impurity studies supporting API and formulation development
- Prepared SOPs, URS, validation protocols, and quality documentation
- Mentored and trained team members on GMP, data integrity, and laboratory compliance
- Successfully supported multiple USFDA and MHRA audits with zero critical observations
- Reduced validation cycle time by 20% through process optimization
QC Officer
Glenmark Pharmaceuticals
09.2013 - 07.2014
- Performed analytical testing (HPLC, dissolution, related substances) for stability samples
- Conducted polymorphic studies using XRD techniques
- Ensured compliance with GMP and internal quality standards
QC Officer
Cipla Ltd.
12.2010 - 09.2013
- Conducted wet chemistry and instrumental analysis (UV, IR, KF, TOC, GC, HPLC)
- Prepared standard/sample solutions and executed routine QC testing
- Supported laboratory compliance and documentation activities
Education
M.Sc. - Chemistry
S.R.T.M.U. Nanded
B.Sc. - undefined
Shivaji University Kolhapur
Skills
Quality Management Systems (QMS)
Regulatory Compliance (USFDA, MHRA, EU, WHO)
Computer System Validation (CSV)
Analytical Method Development & Validation (AMV)
OOS, OOT, OOC Investigations & CAPA
Data Integrity (ALCOA)
Risk Management (ICH Q9)
Audit Management & Inspection Readiness
Change Control & Deviation Management
Team Leadership & Stakeholder Management
Analytical Techniques: ICP-MS, LCMS, HPLC, XRPD, DSC, TGA, RAMAN, NMR, UV-Vis, IR
Validation & Compliance: CSV, IQ/OQ/PQ, GAMP5, 21 CFR Part 11, EU Annex 11
Quality Systems: OOS/OOT/OOC, CAPA, Change Control, Deviation, Risk Assessment
Accomplishments
- Successfully handled USFDA and Health Canada audits (3+ times)
- Recipient of "Unichem Star Award" (2020)
Certification
Polymorphic Studies Training – PANalytical, Netherlands
Interests
Playing Tabla, Flute and Listening classical Music
Timeline
Research Scientist-II
Unichem Laboratories Ltd
08.2014 - Current
QC Officer
Glenmark Pharmaceuticals
09.2013 - 07.2014
QC Officer
Cipla Ltd.
12.2010 - 09.2013
B.Sc. - undefined
Shivaji University Kolhapur
M.Sc. - Chemistry
S.R.T.M.U. Nanded
PERSONAL DETAILS
Date of Birth: 30/06/1986. Marital Status: Married. Languages Known: Marathi, English, Hindi and Konkani Hobbies: Playing Tabla, Flute and Listening classical Music. I assure you that the information given above is true to the best of my knowledge.
COVERING LETTER
- Dear Hiring Manager
- I am writing to express my interest in the Sr. Manager – Quality position. With over 15 years of experience in pharmaceutical quality control, quality assurance, and analytical science, I bring a strong track record of ensuring regulatory compliance, leading validation initiatives, and driving continuous improvement across laboratory and quality systems.
- In my current role as Research Scientist-II at Unichem Laboratories, I have led end-to-end Computer System Validation (CSV) activities, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines. I have successfully managed analytical method validation, OOS/OOT investigations, and CAPA implementation while maintaining strict adherence to data integrity principles (ALCOA+). My experience also includes supporting multiple USFDA and international audits, consistently contributing to successful inspection outcomes.
- I possess deep technical expertise in analytical techniques such as ICP-MS, LCMS, XRPD, DSC, and spectroscopic methods, along with a strong foundation in quality systems, risk assessment, and regulatory compliance. Beyond technical capabilities, I have demonstrated leadership in mentoring teams, optimizing workflows, and collaborating with cross-functional stakeholders to deliver high-quality results within timelines.
- I am particularly excited about this opportunity as it aligns with my experience in strengthening quality systems, enhancing compliance frameworks, and contributing to organizational excellence in the pharmaceutical industry.
- I would welcome the opportunity to discuss how my experience and skills can contribute to your organization’s quality and compliance goals.
- Thank you for your time and consideration.
- Sincerely
- [Vishal B. Sawant]
KEYWORDS INCLUDED FOR ATS
Quality Assurance, Quality Control, GMP, GLP, CSV, Data Integrity, ALCOA+, CAPA, OOS, OOT, Regulatory Compliance, Analytical Method Validation, ICP-MS, HPLC, Audit, Risk Management, Validation Lifecycle, Pharmaceutical Quality