Rasendu Shah
Sr. Associate - Pharma Projects
Diploma in Industrial Managment
Mumbai, 1983
Master in Pharmacy
Gujarat, 1981
Bachelors in Pharmacy
Gujarat, 1979
Thirty Eight Years' of experience in Pharmaceutical operations including production, product development, projects, system implementation, cost reduction, system compliance, audit preparation and execution of role of lead auditor during multiple udits in different organization, complying Regulatory Guidelines of USFDA, EMA, MHRA, PIC(s), ANVIMA, INVIMA, MOH of various countries, a WHO (Geneva) and other reputed regulatory audits of various countries.
Have worked at various levels in different Pharmaceutical organizations from junior level to the highest positions of overall in-charge of technical operations covering various aspects of Pharmaceutical operations. Major areas covered are Production, Quality Control & Quality Assurance, Maintenance, New Projects, Supply Chain Management, Procurement, Labor Management, Costing, Marketing, etc. Excellent capabilities of execution of New Technologies and automation in various Pharma operations and have executed multiple new formulation as well as bulk drug facilities successfully. All facilities have been designed with cGMP norms of International Regulatory Authorities and the new facilities have passed all key International regulatory Audits till date.
Significant Projects
- Design of INSULIN Formulation facility for NOVO NORDISK (Denmark) Products at Torrent Pharmaceuticals Ltd, Ahmedabad
- SVP Facility using Form-Fill-Seal technology for Core Healthcare Pvt Ltd, Ahmedabad
- Cytotoxic (Anti-Cancer) facility for INTAS Pharmaceuticals Ltd, Ahmedabad
- Formulation Development Facility for Cytotoxic Products for Oral Solid & Parenteral products for Shilpa Medicare, Vizag
- Oral Solid & Parenteral Formulation Facility (For US Market) for Cytotoxic Products for Shilpa Medicare (formerly known as Raichem Lifescience Ltd), Jedcherla
- Oral Solid Facility for Cytotoxic Products for Eiman Pharma, UK
- Oral Solid & Parenteral Formulation Facility for Cytotoxic Products for ADHEELS, SOUSSE, TUNISIA (North Africa) (Project under execution)
- API Vaccine facility for H1N1 Vaccine for Cadila Pharmaceuticals Ltd, Ahmedabad
- Fully automatic Parenteral facility for H1N1 Vaccine for Cadila Pharmaceuticals Ltd, Ahmedabad
- Cytotoxic API facility and subsequent forward integration in to formulation unit for Gujarat based upcoming Pharmaceutical Company, Celestis Lifesciences
