Jahnavi Lad
New Jersey,USA
Summary
Quality & Compliance professional with expertise in GMP, FDA, and ICH regulatory standards. Skilled in QMS implementation, auditing, and CAPA management to ensure product quality and regulatory alignment in pharmaceutical and dietary supplement manufacturing.
Overview
6
6
years of professional experience
Work History
Quality Compliance Specialist
Sanofi Consumer Health (Quten Research Institute, LLC)
01.2023 - Current
- Oversee batch release activities by reviewing and approving documentation in compliance with GMP, ICH, FDA, and industry regulations.
- Lead the CAPA process, driving root cause investigations, corrective actions, and preventive measures to ensure sustainable improvements.
- Conduct risk assessments for deviations, out-of-specification (OOS) results, and complaint investigations, ensuring timely and effective closure.
- Monitor batch release performance metrics and leverage data-driven insights to support continuous improvement initiatives.
- Participate in internal and external audits, preparing documentation, addressing findings, and maintaining audit readiness.
- Support implementation, monitoring, and continuous improvement of the Quality Management System (QMS).
- Ensure adherence to internal SOPs, batch records, and regulatory requirements across operations.
- Perform testing of bulk raw materials and in-process blends to verify identity, potency, and purity prior to release.
- Review Certificates of Analysis (COAs), raw material specifications, and finished product test results for compliance and release decisions.
- Collaborate cross-functionally with R&D, Manufacturing, and Supply Chain teams to uphold product quality across all stages of development and production.
- Train and mentor new hires on QA procedures, GMP requirements, and documentation best practices.
Quality Assurance/Compliance Associate
Time-Cap Labs
06.2021 - 12.2022
- Reviewed production and packaging batch records to support product disposition decisions
- Investigated and documented deviations, OOS, and complaints; coordinated CAPA implementation
- Supported vendor qualification, risk assessments, Certificates of Compliance, and APR updates
- Updated SOPs and trained staff to ensure compliance with regulatory requirements
Project Intern – Quality Control & Assurance
CTX Lifesciences India
06.2019 - 09.2019
- Supported QC testing (assay, impurities, dissolution) of APIs and formulations per USP/EP/IP standards
- Assisted QA team in preparing and reviewing GMP documentation and observed deviation investigations
Education
MBA - Healthcare management
Campbellsville University
Louisville, KYM.S. - Pharmaceutics (Industrial Pharmacy)
Long Island University
Brooklyn, NY12.2021
B.Pharm - Pharmaceutical Science
Gujarat Technical University
05.2019
Skills
- Batch Record Review & Final Release
- GMP, GLP, ICH & FDA Compliance
- Risk Assessment & CAPA Management
- Deviation, OOS & Complaint Investigations
- Internal/External Audit Support
- SOP Development & Compliance Training
Timeline
Quality Compliance Specialist
Sanofi Consumer Health (Quten Research Institute, LLC)
01.2023 - Current
Quality Assurance/Compliance Associate
Time-Cap Labs
06.2021 - 12.2022
Project Intern – Quality Control & Assurance
CTX Lifesciences India
06.2019 - 09.2019
M.S. - Pharmaceutics (Industrial Pharmacy)
Long Island University
B.Pharm - Pharmaceutical Science
Gujarat Technical University
MBA - Healthcare management
Campbellsville University
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