JIGNESH SOLANKI

Compliance professional with a proven track record in regulatory adherence and risk management. Specialized in developing and implementing compliance programs that align with industry standards. Recognized for fostering team collaboration and consistently delivering results, while adapting to evolving needs. Proficient in policy development, auditing, and problem-solving, ensuring organizational integrity and building trust.

• GFSI (Global Food Safety Initiative)
• Advanced SQF (Safe Quality Foods) Practitioner
• FSPCA (FOOD SAFETY PREVENTIVE CONTROLS ALLIANCE)
• Foreign Supplier Verification Programs
• Member of ASTM (American Society of Testing Materials) International since 2001
• Received 2.0 CEU for the successful completion of Technical and Professional training for the Introduction to Major Testing Techniques for Plastics Course.
• Member of CfPA (Center for Professional Advancement), 2008
• Received 2.0 CEU for the successful completion of professional training on Conducting Effective Quality Audits.

• Millenium Natural Manufacturing Corporation, 10/01/16, 06/01/17, Performed remediation activities in response to FDA 483’s and Warning Letter. Reestablished GMP business operations with development of QMS procedures and policies.
• Novel Ingredients, 07/01/16, 10/01/16, Provided regulatory leadership for third-party GMP certification, performed quality audits, gap assessment, established risked based supplier qualification program and developed change management program. Responsible for the developing and maintaining Quality Management systems in compliance with FDA CGMP 21 CFR Part 111, 117, FSVP, SQF and NSF requirements.
• Teawolf, 01/01/16, 10/01/16, Developed in-house laboratory capabilities to comply ISO and ICH guidelines for third-party certification. Implemented method validation program, created effective training program for 12 chemists on laboratory compliance initiatives. Managed routine Environmental Monitoring, microbial isolation techniques, and performed Gram stain identifications.
• Dynamic Health Laboratories Inc., 07/01/13, 12/01/15, Provided leadership on the development of corporate GMP certification program, overhauled label review and approval procedures, instituted regulatory review of label specifications for domestic and international markets, developed gap assessment of site GMP procedures, developed internal audit program to assess nonconformance reports, effectiveness of CAPA plans, establishment deviation management program and change management program.
• Maesa Beauty, 01/01/11, 05/01/13, Responsible for developing and managing Global QMS programs across 4 sites (China, Los Angeles, New York and France) for personal care products. Implemented CPSC standards, quality and safety testing program, Developed Global finished product specifications, harmonized testing methodologies across multiple sites. Designed and developed in-house packaging laboratory testing capabilities. Delivered on-time discrepancy reporting of investigations into product complaints, non-conformances and identified deficiencies continuous improvement initiatives.
• The Vitamin Shoppe Inc., 06/01/07, 04/01/10, Established and managed a compliance auditing program for contract manufacturers, ensuring adherence to cGMP surveillance. Developed auditing scopes and activities for various manufacturers and conducted external audits to comply with ICH Q7, 21 CFR Parts 211 and 111, ISO 9001:2015, and other standards. Implemented a corporate-wide, metric-based Supplier Qualification Program to monitor supplier performance, timely remediation to audits, customer complaints, compliance with product testing, and on-time shipment. Created a supplier audit performance monitoring database for tracking corrective action plans and developed a comprehensive investigative program for customer complaints, identifying potential adverse events and ensuring compliance with Proposition 65 through a product testing database.