Deepak Joshi

25+ year of rich experience in pharmaceutical API and intermediates industries. Work in areas with Quality Assurance with Quality control, Analytical development background in regulatory environment.

Head QC/QA - Steviatech Lifesciences - Ahmedabad

(2024-10)

Quality Management System implementation, Validation and Qualification activities of process, cleaning, method system and critical vendor. Support to cross-functional team, internal audit, handling of regulatory and customer audit, ensure timely CAPA implementation, Documentation upgradation and technical training.

• Greenfield project, quality management system setup, QC lab set up in regulatory and export market with compliance framework

AGM Quality Control /Quality Assurance - Neogen Chemical Limited-Bromine derivative Division - Vadodara, Gujarat

(2017-06 - 2024-04)

Overall responsible for all quality related activities and implementation for continuous improvement. Monitoring of Quality Management System, Handling of Audit and ensure its compliance, Monitoring of stability studies, monitoring CAPA for its effectiveness, APQR review, Documentation system, Internal Audit and Technical training, cross function support to site manufacturing team, corporate and business development, management presentation for quality, budgeting and planning.

• Set up of new quality control and QA department in new plant
• Harmonise quality system with other sites of Neogen chemical
• Site readiness for advance niche molecule markets with on-time documentation
• 100 No. Pharma customer audits in first 2 year and its compliance

AGM Quality Assurance - Ami Lifesciences private Limited - Vadodara, Gujarat

(2015-09 - 2017-05)

Quality Management System monitoring, Audit and compliance, Monitoring of stability studies, monitoring CAPA for its effectiveness, APQR review, Documentation system, Internal Audit and Technical training, cross function support to site manufacturing team, corporate and business development, management presentation for quality, budgeting and planning

• First time EDQM success, WHO audit compliance, Turn Quality culture than ever before

Manager QA - Glenmark Pharmaceutical Limited - Bharuch, Gujarat

(2013-03 - 2015-09)

Team leader of Investigation and compliance, team leader of Vendor Qualification, External manufacturing coordinator, Quality indicator presentation, technical trainer

• 243 No. Vendor handling and 11 outsource manufacturing site handling
• Convert 5 chemical companies in GMP culture
• Team member of USFDA and MHRA audit

Manager QA - Lupin Limited - Vadodara, Gujarat

(2006-02 - 2012-08)

Monitoring of Quality management System, Handling of noncompliance, market compliant, first time qualification and validation at Vadodara site with help of lupin CQA and other regulatory sites, internal audit, cross function support to technical liason work, Tracking of change control and out of specification, trend and APQR preparation, harmonization of QMS with other lupin site.

• Team member for converting acquired site of Lupin from Rubamin
• Convert site successfully from non GMP to TGA and USFDA

Research Associate-ADL-DQA - Sun Pharmaceuticals - Vadodara

(2002-05 - 2006-05)

• Analytical method development protocol and report review, stability studies, method transfer
• Operation, calibration for HPLC, LC-MS, XRD, NMR, UV-VIS, IR, GC, GC-HS and wet analysis
• DQA, DHR review, TT review etc

QC-QA Chemist - Dishman Pharmaceutical - Ahmedabad, Gujarat

• RM, FG Testing and dispatch/GMP co-ordinator
• Operation GC, HPLC, HPTLC, IR, UV, etc.

Training QC chemist - RPG Lifesciences and Sanofi Aventis - Bharuch, Gujarat

• QC chemist, calibration, testing of RM, IPQC, FG, Document and Label issue

Post graduate - Chemistry

P.G Diploma - Quality