Jyoti Ingale

Quality Assurance and Regulatory Affairs professional with 15+ years of experience in USFDA-regulated pharmaceutical environments. Expertise in regulatory compliance, GMP/GLP standards, documentation control, quality management systems, and audit readiness. Experienced in supporting regulatory documentation, compliance assessments, and regulatory inspection preparation.

Strong background in USFDA and ISO audits, data integrity (ALCOA+), and cross-functional coordination to ensure adherence to global regulatory requirements.

Compliance – Quality Assurance Executive - ENEM NOSTRUM REMEDIES PVT. LTD.

(2011-04 - 2024-05)

USFDA Approved facility. Successfully participated in three USFDA audits. Supported ISO certification and recertification audits. Ensured regulatory compliance for QC laboratory operations and documentation.

• Ensured compliance with GLP, GMP, and ALCOA+ data integrity principles in QC laboratories.
• Managed Quality Management System (QMS) including Deviation, CAPA, Change Control, and LIR processes.
• Reviewed and approved documentation related to calibration, equipment qualification, and laboratory operations.
• Conducted internal audits and supported third-party and regulatory audits.
• Supported Regulatory Affairs activities to ensure compliance with USFDA, GMP, and global regulatory requirements.
• Monitored temperature, humidity, and time synchronization systems.
• Maintained instrument calibration schedules and equipment history records.
• Tracked analytical data trends and monitored AMCs and yearly maintenance schedules.
• Issued controlled QA documents and maintained documentation control systems.
• Trained new staff on SOPs, laboratory compliance, and regulatory requirements.
• Coordinated with cross-functional teams to maintain quality and regulatory compliance standards.

Quality Assurance Officer - QA TECH (A Division of GMP Technical Solutions Pvt. Ltd.) – A CIPLA LTD. Enterprises

(2008-12 - 2011-04)

• Supported QA and compliance activities for ISO audits.
• Reviewed IQ/OQ/PQ qualification documentation for laboratory instruments.
• Prepared and implemented Standard Operating Procedures (SOPs).
• Assisted in establishing and maintaining Quality Management Systems (QMS).
• Participated in Management Review Meetings and internal audits.
• Managed Deviation, CAPA, and Change Control processes.

Post Graduate Diploma - Regulatory Affairs - RamNiranjan Jhunjhunwala College (2025)

M.Sc. - Chemistry - Swami Vinayaka (2013)

B.Sc. - Chemistry - Mumbai University (2008)

HSC - Mumbai University (2005)

SSC - Mumbai University (2003)