Maheshwar Tripathi

About Maheshwar Tripathi

I am a certified ISO 9001:2015 Lead auditor with over 19 years of extensive experience in Quality Management, specializing in the Pharmaceutical industry. My expertise spans various formulations, including Tablets, Capsules, Multi-dose Inhalers, Dry Powder Inhalers, Pellets, and Injectables.I have had the privilege of working alongside renowned industry experts, including Ex. USFDA auditors Dr. Ademola Daramola and Dr. Massoud Motamed during my tenure at Cipla Ltd. My career has been marked by the development of Quality Management Systems aligned with regulatory requirements and successfully clearing audits from organizations such as WHO, MHRA (UK), USFDA, ANVISA (Brazil), Ukraine, and Uganda.My knowledge extends to GMP (FDA, EU & ICH), QMS, Investigations, Medical Devices (Combination Product), Manufacturing & Packaging Assurance (IPQA), and Audit & Compliance. I have interacted with regulatory auditors such as Ms. Nicole E. Knowlton (USFDA), Ms. Di Morris (MHRA), and Ms. Edit SZOCS (WHO Geneva).Throughout my career, I have excelled in problem analysis, proposing effective solutions, and implementing recommendations to support departmental goals. I have a track record of formulating SOPs/policies, designing processes, and establishing supplier partnerships to enhance operational efficiency and achieve cost savings targets.My leadership style emphasizes teamwork, mentoring, and a drive to turn visions into reality while balancing employee needs with organizational mandates. I have consistently ensured in-process quality, continuous improvement, and effective quality control inspections.In my current role as Assistant General Manager at Wallace Pharmaceutical Pvt. Ltd, I am driving the establishment of robust quality standards, compliance, and a culture of quality excellence. I have successfully implemented a quality management system and commissioned a greenfield facility.I hold a Master of Science in Pharmaceutics from BITS, Pilani, and a Bachelor of Pharmacy from Pune University. I am a certified ISO 9001:2015 Lead auditor and proficient in IT tools, including MS Office, SAP, Trackwise, and other training and document management systems.I am passionate about driving quality and compliance within the pharmaceutical industry and remain committed to staying updated with the latest developments and standards in pharmaceutical quality management.

Experience

1. Lead Quality Compliance

   Dr. Reddy's Laboratories

   Feb 2024 — Present · Hyderabad, IN

   Lead, facilitate, and monitor workstreams focused on quality improvement, cultural transformation, and audit readiness program (SuCCEED) across various Dr. Reddy\'s sites, both domestic and overseas- Ensure site compliance with Lean daily management practices, Gemba, self-inspection, all-time audit readiness, and adherence to procedures-Ensure thorough investigations are conducted with proper root cause analysis and corrective actions, providing support to effectively close out issues and maintain compliance across Dr. Reddy\'s sites- Serve as the custodian of program workstreams, providing an independent view on progress and coaching site teams to drive the program effectively- Conduct independent diagnostics of sites to assess current performance and identify areas for improvement- Manage the overall program, including presenting progress updates and site performance comparisons in management reviews- Work closely with site teams to plan, execute, and control workstream interventions, milestones, metrics, and outcomes, ensuring alignment with key performance indicators (KPIs) and continuous improvement goals- Provide coaching and training to site teams to enhance investigation quality and robustness, reducing laboratory/human errors and repeat deviations- Drive culture transformation initiatives, communication strategies, and capability building programs to foster a culture of quality and continuous improvement- Maintain program sustainability through regular communication on program benefits, and implement reward and recognition mechanisms to motivate teams- Collaborate with stakeholders to identify opportunities for improvement and implement best practices across sites.

Education

• Karnataka Bank

  Associate of Pharmacy

• Birla Institute of Technology and Science, Pilani

  MS, Pharmaceutics

  2009 — 2012

• Pune University

  Bachelor of Pharmacy

• BITS-PILANI

  Master of Science, Pharmaceutics and Drug Design

Skills

• Documentation
• Pharmaceutics
• Regulatory Audits
• Ipqa
• Anda
• Change Control
• Regulatory Affairs
• Pharmaceutical Industry
• Sop
• Fda
• Internal Audit
• Gmp
• Formulation
• Cgmp Manufacturing
• Quality System
• Validation
• Vendor Audit
• Vendor Management
• Capa
• Vendor Relations
• Quality Assurance