Rahul Sareen

WORK HISTORY

EDUCATION

SKILLS

ABOUT RAHUL SAREEN

An experienced Pharmaceutical professional with over 20 years of experience encompassing Product Development, Technology Transfer and Quality (Operations and Compliance) for API\'s, Parenteral, Radio Pharmaceuticals and Oral Solid Dosage forms. Extensive experience in successfully hosting regulatory inspections, and writing timely and effective response to any observation. Successful in establishing compliance enhancement initiatives, performing gap assessment and implementing long-term corrective actions for a continuous supply of drugs to the market place. Thorough understanding of various validation programs and successfully managed and implemented continuous process improvement initiatives. Thorough understanding of post approval regulations and change management. Successfully applied QbD principles for process enhancements to enhance control strategies and improve process efficiency. Successfully managed various quality compliance functions like Training, Document Control, Change Management, Validations, Audits, Complaints, Quality Operations, Stability, CAPA, Investigations, Management Notifications, Quality & Efficiency Metrics and Process Enhancement s to ensure efficient and cost-effective operations, resulting in shorter product release times, compliance and high first time right rate.Successfully remediated Warning Letters and Consent Decree through gap analysis and effective remediation plan. Developed several oral immediate and modified release solid dosage forms for registration in advanced regulated markets. Developed novel and value added formulations and patented some of these inventions to add to the company’s intellectual property.