Sagar Phopase

About Sagar Phopase

An experienced expert having strong background of working in formulation development and Process development (PDL) of OSD (Including Hormone) and Semisolid dosage forms for various regulatory as well as ROW market.LSSGB certified. Well acquainted with various Technology Transfer activities, trouble shooting, scale-up/ scale down techniques and Validation.Expert in pellet technology. strong knowledge of various regulatory guidlines, and QbD based process development.Rich experience in process development, technology transfer, site transfer, cost reductions, process improvements in OSD, Semisolid, and Hormones.

Experience

1. Sr Manager- Technical Services (Manufacturing Science & Technology)

   Ipca Laboratories Limited

   Jun 2024 — Present · Indore, IN

   Technical: Provide all technical inputs for new product launch, site transfer projects, regulatory filing and post approval variation filing / SUPAC, continuous improvement in product, investigations, trouble shootings, batch size scale-up and scale down, machine selection and capacity utilization, new machine procurement / up-gradation of existing machines, toolings etc.Technology transfer: Moving technology from internal and external sources into manufacturing including new product launch & site transfer projects.Process improvement: Streamlining processes, reducing cost and time, and optimizing manufacturing efficiency Process validation: Ensuring that processes meet performance qualifications. Optimization of various CPP’s and evaluates their impact on drug product CQA and QTPP. Freezing of process and parameters though Pre-validation and validation.Risk assessment: Identifying opportunities for quality improvements, identifying the risk, and mitigation plan.Project management: Managing the various project at site (New launch/ site transfer). Planning and assigning the work to subordinates. Communicate between various stakeholders to move the project. Product life cycle management: Managing the product life cycle after commercialization, troubleshoot the commercial issues, improve process capability index (CpK, PpK), and tracking and evaluation of process and product quality though various controls charts.Investigations: Investigation of various incidences/ OOS/OOT in commercial products, Provide technical support to site investigation team to identify root cause and provide necessary CAPA. Review of investigation reportRegulatory compliance: Ensuring that products and processes meet regulatory requirements Documentation: Technically review all the relevant documents like, batch records, protocols, reports, investigations. Evaluation of various QMS documents like Change control, Deviations, OOS, OOT incidences, CAPA in Trackwise system.

Education

• MES College of Pharmacy

  B.Pharm, Pharmacy

  2006 — 2009

Skills

• Generic Programming
• Anda
• Process Development, Technology Transfer, Validation, Trouble Shooting
• Technology Transfer
• Formulation
• Drug Delivery
• Pharmaceutical Research
• Validation
• Gmp