Ranjan S Sharma

Compliance Lead | 18+ Yrs in Pharma QA, QC & Manufacturing | Compliance remediation | QMS | Inspection Readiness| IPQA | Validation | Investigation, CAPA, Risk Mgmt, Six sigma | Project mgmt.| Digital Transformation| MES

Role
Compliance Lead (General Manager) at 辉瑞
Location
Visakhapatnam, AP, IN
LinkedIn followers
500 followers

About Ranjan S Sharma

With 18 years of experience in Quality Assurance in Pharmaceutical Industry, I am a dedicated Compliance lead-General Manager known for driving excellence and innovation in quality operations, compliance, and regulatory adherence. My career is marked by a series of significant achievements and a proactive approach to quality management.My effective skills include Leadership, Team Management, Strong communication and interpersonal skills, Project Management, Certified Quality Auditor, Experienced in USFDA, MHRA, TGA and WHO audit, Lean Six Sigma Green Belt, Effective Communication, Strong knowledge of cGMP regulations and regulatory guidelines, Deviation management, CCF and QRM.In my current role, I lead a team of QA professionals responsible for optimizing quality compliance and operation processes and enhancing manufacturing efficiency to meet established KPIs. My leadership has been pivotal in spearheading the successful completion of USFDA inspections and regulatory audits, resulting in a significant status change from OAI to VAI.I excel in leading cross-functional teams (CFTs) to conduct thorough risk assessments, root cause analyses, and develop CAPA plans that efficiently address quality issues. My expertise extends to conducting both internal and external audits to ensure compliance and drive necessary corrective actions.Throughout my career, I have collaborated with cross-functional teams to promote continuous improvement initiatives and revolution projects, all aimed at maintaining the highest quality standards. By implementing strategic measures, I have successfully enhanced efficiency and streamlined QA operations, achieving a notable 58% reduction in deviations and a 47% increase in product quality.My efforts in improving QMS processes have resulted in 100% on-time closure of deviations, CCFs, and CAPA, along with a 52% increase in the Manufacturing to Release cycle time. Additionally, I have conducted 34 Lean Six Sigma projects, which have contributed to achieving zero repeat deviations over the past year.I am passionate about driving continuous improvements and ensuring that quality standards are not only met but exceeded. Connect with me to learn more about how we can collaborate to elevate quality operations and regulatory compliance to new heights.

Experience

  1. Compliance Lead (General Manager)

    辉瑞

    May 2025 — Present · Visakhapatnam, IN

Education

  • BPUT,Orissa

    Bachelor of Pharmacy (B.Pharm.)

    2004 — 2008

  • Indian Institute of Management Visakhapatnam

    Master of Business Administration - MBA

    2022 — 2024

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Ranjan S Sharma — Compliance Lead (General Manager) at 辉瑞 in Visakhapatnam, AP, IN | Unifers