General Overview

• Member of CQI/IRCA.
• IRCA Certificated Lead Auditor (PQMS-GMP).
• ISQSH Certified Pharmaceutical GMP Auditor.
• ISQSH Certified Lean Six Sigma Black Belt.
• ISO Certified Lead Auditor for ISO 9001, 14001, 45001, 13485, 22000, 14298
• Currently serving as a Lead Auditor:
  • Conducting supplier qualification audits and certification audits globally.
  • Performing GAP analysis and risk assessments.
  • Imparting training on all the above management systems

Core competencies:

Pharmaceutical Quality Management Systems (GMP)

• Extensive experience in conducting thorough audits of pharmaceutical manufacturing facilities, ensuring compliance with GMP, GDP, and other quality standards.
• Skill in implementing risk-based QMS processes to identify and mitigate quality risks.
• Proficient in driving corrective and preventive actions to enhance product quality.
• Ability to lead PQMS audits effectively, ensuring compliance with GMP.
• Experience in conducting audits in various countries
• Ability to oversee batch release processes, ensuring product quality and compliance
• Competence in establishing and monitoring quality metrics to drive continuous improvement.
• Skilful handling of investigations, deviations, and root cause analysis.
• Familiarity with Lean principles and Six Sigma methodologies

Quality Control

• Proficiency in using analytical instruments like HPLC (MS), GC (MS), and UV-Vis spectroscopy for testing and analysis.
• Strong understanding of chemistry principles and pharmaceutical manufacturing processes
• Familiarity with quality standards and regulations in the pharmaceutical industry, such as GMP, GLP, and ICH guidelines
• Ability to accurately record, analyse, and report laboratory data.
• High level of precision in conducting tests and interpreting results.
• Ability to troubleshoot issues related to analytical testing and equipment.
• Ability to effectively communicate with other departments to ensure quality standards are met.
• Proficiency in using laboratory information systems and software for data analysis.
• Commitment to staying updated with advancements in analytical chemistry and pharmaceutical quality control

Injectables

• Expertise in EU GMP Annex 1, FDA, EMA, and MHRA guidelines for sterile manufacturing and batch release.
• Strong knowledge of cleanroom operations, sterility assurance, and contamination control in injectable production.
• Microbiology & Sterility Testing – Proficient in endotoxin testing (LAL), microbial limit tests, environmental monitoring, Particulate matter analysis and media fills.
• Process Validation & Equipment Qualification – Experience in sterilization techniques, process validation, and automated injectable filling systems.
• Skilled in HPLC, GC, UV spectroscopy, and dissolution testing for injectables.
• Understanding of nanoparticles, liposomal formulations, and controlled-release injectables.

Accomplishments Highlights

• 21 CFR Part 11 Compliance Implementation: Led deployment of Shimadzu Lab Solution CS, Chromeleon, and Waters Empower network servers at Fleming, Shasun, and Sai Lifesciences.
• QMS Migration to Paperless Documentation
• Successfully implemented SAP system in QA at Fleming.
• Led Track-wise QMS migration at Strides
• Hosted 3 EDQM and 5 USFDA inspections as Head of Quality & Regulatory Affairs, securing approvals.

Resolved six DMF deficiencies reported by EDQM and USFDA, obtaining CEP approvals for six APIs.

Summary of Industry Expertise:

Proven leader over two decades of experience in various pharmaceutical industries as Microbiologist, QC/QA & Regulatory Head.

Quality Assurance Manager

• Proficient in implementing & maintaining quality systems.
• Expertise in identifying & setting quality assurance standards.
• Strong knowledge of quality assurance methodologies & tools.
• Experience in conducting audits & recommending improvements.

Regulatory Manager

• Deep understanding of regulatory guidelines and procedures in the relevant industry.
• Ability to ensure that the organization complies with all current regulations.
• Proficient in preparing and submitting documentation to regulatory agencies.
• Expertise in staying updated with regulatory changes and advising the organization accordingly.
• Strong communication skills to liaise with regulatory bodies.

Quality Management System and GMP Auditor

• Proficient in conducting audits of Quality Management Systems (QMS) and Good Manufacturing Practices (GMP).
• Strong knowledge of QMS and GMP principles and standards.
• Ability to analyze and interpret data related to QMS and GMP.
• Expertise in identifying non-compliance issues and areas for improvement in QMS and GMP.
• Excellent report writing skills to present audit findings