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.
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.
Education
Bachelor's Degree in Operations
Sikkim Manipal UniversityJan 2010 - Jan 2012 - 2 yr
Bachelor's Degree
NMU UniversityJan 2000 - Jan 2003 - 3 yr
Skills
- Quality Assurance
- Regulatory Affairs
- Pharmacovigilance
- Production Planning
- Warehouse Management
- Microsoft Word
- SAP
- excel
- Ppt
- CHARTS
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Languages
English
FluentHindi
FluentMarathi
Fluent