Sohini Joardar
Risk Management Specialist |Internal Audit |cGMP Expertise | FCPA Investigation
Hyderabad
Summary
Risk Management Specialist with over 13+ years of expertise in Enterprise Risk Management (ERM), Compliance, Internal Audit, Quality Assurance, and Foreign Corrupt Practices Act (FCPA) investigations. Demonstrated track record in mitigating critical risks, executing internal and cGMP audits, and upholding regulatory compliance. Skilled in Quality Management Systems, emphasizing process uniformity and ongoing enhancements to maintain product quality and safety standards.
Overview
14
14
years of professional experience
3
3
Certifications
3
3
Languages
Work History
Risk Management Specialist
Dr. Reddy’s Laboratories – Corporate
09.2021 - Current
- Identify, analyze, and track key risks and compliance issues across global business units using a structured ERM framework.
- Support quarterly management reviews by presenting risk insights and updates.
- Conduct annual risk assessments, and support proactive risk mitigation strategies.
- Analyze emerging risk trends impacting business performance.
- Update risk factors for SEC Form 20-F disclosures through stakeholder collaboration and peer benchmarking.
- Contributed to Business Continuity Planning (BCP) initiatives to ensure process resilience.
- Delivered actionable insights via dashboards and risk heat maps.
FIDS Consultant
Ernst & Young (EY)
02.2020 - 09.2021
- Conducted forensic investigations into fraud, bribery, and whistleblower allegations, with a focus on FCPA compliance.
- Supported dispute resolution through data analysis and financial reviews.
- Supported Anti-Bribery and Anti-Corruption (ABAC) program execution, including third-party due diligence and background screening.
- Utilized forensic tools (Relativity) and analyzed large datasets to detect anomalies and red flags.
- Led cGMP reviews of pharmaceutical industries to ensure regulatory compliance.
- Prepared investigative reports and delivered findings through client-facing presentations.
Internal Audit Associate
Dr. Reddy’s Laboratories – Corporate
10.2017 - 01.2020
- Executed cGMP and 21 CFR Part 11 audits across pharma sites in India and abroad.
- Conducted audits across key operational areas, including scrap management, vendor management, supply chain, and R&D functions.
- Developed risk-based audit programs, and delivered reports with root cause analysis and recommendations.
- Facilitated training programs to enhance awareness and team capabilities.
Experience in Quality Assurance
Dr. Reddy’s Laboratories – CTO 2 (Nov 2014 – Oct 2017) | Hikal Ltd. (Jul 2012 – Oct 2014) | Hiran Orgochem Ltd. (Nov 2011 – Jul 2012)
11.2011 - 10.2017
- Gained hands-on experience in Quality Assurance functions across leading pharmaceutical companies.
- Conducted quality investigations (OOS, OOT, deviations), root cause analysis, and implemented CAPA.
- Managed Change Control processes, prepared and reviewed APQRs, BMRs, SOPs, validation protocols and reports, and equipment qualification documents.
- Familiar with SAP and LIMS.
- Participated in regulatory audits, like USFDA, EDQM, ANVISA, FAMHP, and others.
Education
Master of Science - Biotechnology
Roland Institute of Pharmaceutical Sciences
Berhampur University 04.2001 -
Bachelor of Science - Molecular Biology & Biotechnology
Kalyani Mahavidyalaya
University Of Kalyani 04.2001 -
Skills
- Risk assessment and compliance
- Internal audits and cGMP compliance
- FCPA compliance investigations
- Quality systems management
Certification
- ISO 9001:2015 Lead Auditor (Quality Management System) – CQI & IRCA
Accomplishments
- Digitization of Key Risk Indicators: Improved efficiency and accuracy of risk tracking by digitizing KRIs, enabling proactive risk mitigation and data-driven decision-making.
- Lean Six Sigma Yellow Belt: Led a project to analyze and reduce recurring GMP observations across global sites, improving audit readiness and compliance outcomes.
- BMR Simplification: Streamlined batch manufacturing records (BMRs) using pre-filled fields, simplified language, and flowcharts—achieving a 38% reduction in data entry errors
- Lean Daily Management Implementation: Boosted operational efficiency and quality through daily huddles, visual management tools, and standardization of work processes.
- Zest Recognition Award – Honored for outstanding support in the End to End Compliance Forum and key contributions to the oversight of hazardous chemical reviews at the board's request.
- Masters of Risk – Healthcare & Pharma (India Risk Management Awards, CNBC-TV18 & ICICI Lombard) Recognized as part of the award-winning team for excellence in risk management
Timeline
Risk Management Specialist
Dr. Reddy’s Laboratories – Corporate
09.2021 - Current
FIDS Consultant
Ernst & Young (EY)
02.2020 - 09.2021
Internal Audit Associate
Dr. Reddy’s Laboratories – Corporate
10.2017 - 01.2020
Experience in Quality Assurance
Dr. Reddy’s Laboratories – CTO 2 (Nov 2014 – Oct 2017) | Hikal Ltd. (Jul 2012 – Oct 2014) | Hiran Orgochem Ltd. (Nov 2011 – Jul 2012)
11.2011 - 10.2017
Master of Science - Biotechnology
Roland Institute of Pharmaceutical Sciences
04.2001 -
Bachelor of Science - Molecular Biology & Biotechnology
Kalyani Mahavidyalaya
04.2001 -
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