RS

Rupesh Surana

Head Quality Assurance, Regulatory Affairs & Pharmacovigilance at Shelys Pharmaceuticals Ltd

Work Experience

  • Head Quality Assurance, Regulatory Affairs & Pharmacovigilance

    Shelys Pharmaceuticals Ltd

    Feb 2019 - Present -6 yrs, 3 months

    Tanzania

    • Job Details:Successfully led the quality, regulatory, and pharmacovigilance teams, ensuring robust compliance across all operations. Designed and implemented a company-wide quality management system (QMS) aligned with CGMP, TMDA and other regulatory standards, reducing deviations. Acted as a qualified person for pharmacovigilance (QPPV), managing product safety data and ensuring 100% compliance with GVP regulations.
  • Manager — Production Planning

    Rusan Pharma Ltd

    Nov 2015 - Feb 2019 -3 yrs, 3 months

    • Job Details:Managed production planning across three manufacturing sites, ensuring alignment with sales forecasts, regulatory timelines, and resource availability. Designed and implemented capacity planning models to balance workload and optimize utilization of workforce and equipment.
  • Assistant Manager — Production

    Dr. Reddy Laboratory, FTO. 3 (Generics)

    Apr 2010 - May 2014 -4 yrs, 1 month

    • Job Details:Supervised day-to-day manufacturing operations in the oral solid dosage (OSD) division, ensuring compliance with CGMP and regulatory guidelines. Prepared and reviewed master production records (MPRs), batch production records (BPRs), and SOPs to maintain documentation accuracy.
  • Production Officer

    Ajanta Pharma Ltd

    Nov 2009 - Apr 2010 -5 months

    • Education

      • Bachelor's Degree in Operations

        Sikkim Manipal University

        Jan 2010 - Jan 2012 - 2 yr

      • Bachelor's Degree

        NMU University

        Jan 2000 - Jan 2003 - 3 yr

      Skills

      • Quality Assurance
      • Regulatory Affairs
      • Pharmacovigilance
      • Production Planning
      • Warehouse Management
      • Microsoft Word
      • SAP
      • excel
      • Ppt
      • CHARTS
      View More

      Languages

      • English

        Fluent
      • Hindi

        Fluent
      • Marathi

        Fluent
      Share this Profile