Janvi Chokshi
Quality leader
- Role
- Associate Director, Quality Assurance at Tourmaline Bio
- Location
- Newark, CA, US
- LinkedIn followers
- 500 followers
About Janvi Chokshi
Highly skilled Quality Assurance professional with extensive experience in the Medical Device, Biotechnology and Pharmaceutical industry. Certified ISO 13485:2016, Lead Auditor ISO 19011:2018, GLP and IVDR showcases my knowledge and dedication to Quality and Regulatory compliance.Working knowledge and understanding of ICH, FDA (21 CFR 820, 211, 210, 11, and 58) and EU regulations. Strong knowledge about implementation of eQMS and MES systems, Six Sigma tools and Lean manufacturing tools with Masters focused in Quality Assurance in Manufacturing Area from California State University Dominguez Hills.
Experience
Associate Director, Quality Assurance
Jun 2024 — Present
Provide strategic leadership to develop, establish, and maintain the QA programs, policies, and procedures to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.• Perform record review and product disposition activities for Tourmaline materials and products.• Coordinate investigations with vendors and interdepartmental teams to resolve potential quality issues, mitigate risks, and ensure that appropriate corrective/preventative actions are identified and implemented.• Oversee the generation, review and/or approval of internal and external documents used in GMP activities.• Support device design control activities and documentation reviews, including preparation / maintenance of Device History File.• Support the management and continuous improvement of quality systems, including but not limited to supplier qualification, change management, product complaint management, quality management review, and deviation/CAPA management.• Ensure that Tourmaline and its vendors are inspection-ready for health authority inspections by regulatory agencies. • Drive efficiency and support the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing (filling, labeling, packaging, and distribution).• Review and/or approve various documents such as, but not limited to, manufacturing, testing and labeling / packaging batch records, risk assessments, specifications, and protocols and reports for stability and qualification / validation activities.• Perform data integrity and compliance assessments including review against source documents for regulatory submissions.• Author templates, work instructions, standard operating procedures and other documentation to support GMP activities.
Education
B. S. Patel Institute of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2006 — 2010
California State University-Dominguez Hills
Masters in Quality Assurance, Manufacturing Engineering
2014 — 2016
Skills
- Process Improvement
- Content Management and Publishing
- Management
- Regulatory Affairs
- Biotechnology
- Quality Assurance
- Market Research
- Pharmaceutical Industry
- Validation
- Project Management
- Microsoft Excel
- Pharmaceutical Sales
- Research
- Leadership
- Pharmaceutics
- Public Speaking
- Lean Six Sigma
- Microsoft Office
- Competitive Analysis
- Communication
- Team Management
- Gmp
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