Sushil Chaudhari.

About Sushil Chaudhari.

Lead vendor audit, write reports and follow up on vendor audits of domestic and foreign suppliers of API, Regulatory starting material, Packaging Components, Contract service providers like testing lab (GLP), other outsourcing units that are being considered for use as processors/packagers of API & Drug product. Compilation of CMC responses as per targets, Technical package review, Knowledge-sharing with stakeholders (R&D/Analytical) on latest requirements of regulatory bodies aiming to achieve quality filings and product approval within the defined timelines, Nitrosamine Assessment, Potential GTI evaluation in-line with ICH M7, ROS Evaluation for Starting material, intermediate and Drug substance, Responses to queries received from regulatory agencies and to ensure timelines and complaints with regulatory standards. Worked in Global Audit and Compliance at group manufacturing locations. Experience in QMS remediation projects and actively participated in due diligence audits with specific focus on Data Integrity. Experience in manufacturing sites of Bulk API (Manufacturing, Quality Control and Quality Assurance) and Finished Dosage Formulations (IPQA, Quality Assurance, CQA and GQA). Prepare all associated documentation including audit plans and audit reports under strict confidentiality and review Corrective and Preventive Actions for appropriateness and submit for closure in TrackWise. Managed contact manufacturing locations in Cipla, Alkem & Emcure. Successfully managed various regulatory and customer audits like: USFDA, EDQM, PMDA, KFDA, WHO, TGA and various domestic & international customer audits. Ensured quality system compliance of manufacturing facility with respect to standard operating procedures and regulations. Design various training programs and provided training to employees on Good Manufacturing Practices, QMS and regulatory requirements. Manage all Quality Notifications such as Deviations, Change control Management, OOS, Product complaints, Failures and other system related issues. Carry out routine analysis of incoming raw materials, packaging materials and finished products as per approved test methods and ensure they are completed in a timely manner. Awareness and hands on experience in handling o analytical instruments such as HPLC, GC, TOC etc Active co-ordination with planning, production, warehouse and QC colleagues. Responsible to follow ALCOA+ principles and practices during their routine work and to create awareness to shop floor team to reduce the ALCOA+ errors.

Experience

1. Agm - Quality Assurance

   Ipca Laboratories Limited

   Nov 2024 — Present

   24*7 Site Inspection Readiness, QA oversight on Validation & Qualification of processes, methods and CSV.Batch Release, APQR, Audit & Compliance.Technical Agreements, Supplier Quality, Management Review. Management of Quality Notifications. Lead Vendor audit of KSM & Pkg materials. Handling eDMS, LIMS & TrackWise.

Education

• Savitribai Phule Pune University

  Master of Science (MSc), Analytical Chemistry

  1999 — 2001

• New English School, Jamner Dist.Jalgaon

  HSC, Science

  1993 — 1994

• North Maharashtra University

  BSc (Chemistry), Jalgaon

  1996 — 1997

• Savitribai Phule Pune University

  Diploma in Business Management

  1998 — 1999

Skills

• Internal Audit
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• V&V
• Documentations
• License Management
• Documentation
• Gc-Ms
• Pharmaceutical Industry
• Sop
• Glp
• Sap
• Validation
• Dmf
• Vendor Audit
• Hplc
• Abbreviated New Drug Application (Anda)
• Equipment Qualification
• Dissolution
• Quality Management
• Dossier Preparation
• Instrumental Analysis
• Technology Transfer
• Analysis
• Good Laboratory Practice (Glp)
• Standard Operating Procedure (Sop)
• Analytical Method Validation
• Training Management
• Verification and Validation (V&V)
• Anda
• Quality Assurance