Shashi Kumar

Gm, R & D-ard @Ravenbhel Healthcare Pvt Ltd

Jammu, IN

Oversee multiple projects in the analytical development pipeline, ensuring they meet timelines, budget constraints, and quality standards.Establish priorities for the analytical development team in alignment with the company’s product development goals.Identify areas for improvement and implement new technologies or methods to enhance efficiency and accuracy.Develop and manage the budget for the Analytical Development department.Ensure that the team operates efficiently and is aligned with organizational goals.Work closely with Regulatory Affairs to ensure that analytical data supports regulatory filings and inspections.Ensure optimal allocation of resources (personnel, equipment, materials) to meet the department\'s objectives.Conduct risk assessments related to analytical methods and product stability.Responsible for departmental activities covering method development, method validation, stability studies, method transfer activities.Responsible for approval of Specifications for raw materials, excipients, finished products and related Standard Test Procedures (STPs), General Test Procedures(GTPs).Coordinate cross functional teams for qualification of alternate vendors in association with Formulation Development and Purchase departments.Handling regulatory queries, dossier requests, related to finish products like Method validations, Specifications and Certificate of Analysis (CoA), CTD dossiers etc.Supporting QA divisions in the evaluation of market complaint samples, OOS/OOT of commercial stability studies. Responsible to ensure R&D support to QA for facing regulatory audits through necessary documents.

London School of Business Administration

Professional Certificate in Leadership and Professional Programme

Jamia Hamdard

Advanced Diploma in Drug Regulatory Affairs

SSA Business Solutions

Certificate Course (Offline - Continuing Education)

+2 High School Sector: 2D, Bokaro Steel City (Jharkhand)

12th Class

Maratha Mandal College of Pharmacy, Belgaum

B.Pharmacy

KLE COLLEGE OF PHARMACY, BELGAUM

M.Pharm (Pharmaceutical Chemistry)