Durgesh U. Yeole

An increasingly responsible position in Pharmaceutical industry, where multidisciplinary skills and dynamic environment is the foundation for high quality results.

• Deepak, Gogna, Sr. Manager, 08511143075, Amneal Pharmaceuticals Co. Pvt. Ltd.
• Prabhash, Jatav, AGM, 09981699944, Mylan Laboratories Ltd., Indore

• Total experience: - Around 8 years and 2 months
• Post Graduates Pharmacy Professional with having around 8 years and 2months of Experience in Technology Transfer, Process development and Process Validation and Site Transfer activities.
• Credited for several FTF filling and ANDAs
• Credited for Loan license activity.
• Well versed with latest software used SAP, Track wise, DCM and LMS.
• Proficient in handling Site Transfer and Tech transfer Activities.
• Skilled in Trouble shooting of commercial products within regulatory framework.

• Responsible for Oral solid dosage (B Block) and Carbapenem (Penem Block) block activities.
• As well as responsible for loan license activities.
• CO management at Dewas Site.
• Technology from R&D /other location and transfer to planned manufacturing site.
• To monitor process development batches (e.g. Feasibility batches, optimization batches, exhibit batches, registration batches, pre validation batches, commercial validation batches etc.) as per provided plan & checking /review of related documents.
• Process Performance Qualification (PPQ) of New /Existing products and related documents.
• Support plant on product technical issues/trouble shooting activities.
• Support for quality improvement /cost reduction /productivity improvement.
• Review of Master Formulae, Process Validation Protocol /Report & other process development documents.
• Issuance /Retrieval/Revision of Existing/ New SOP’s for PDL process area.

• Support to execute of Scale up, exhibit batches & validation batches at site for US & Europe market & monitoring the same.
• Preparation & review of Scale up BPR, & monitoring activities of scale up batch.
• Scale up data compilation.
• Preparation & review of scale up & exhibit batches summary report.
• Review of stability protocol & sampling matrix of Exhibit batches.
• Correspondence with stakeholders departments, QA, QC, production for smoothening operation.
• SAP related activities (stock overview, material reservation, COA receipt etc.)

• To monitor new product launching (i.e. Scale-up and exhibit batches) and validation.
• To assure & implement the GMP, SOP in the above-related areas.
• Overall responsible for manufacturing, packing and pilot plant activities.
• To review documents (BMR, SOP)
• To ensure proper utilization of machineries, compliance of SOP’s.

• GATE qualified with score 93.63% in Pharmaceutical Sciences Conducted by IIT Mumbai held in Feb 2005.
• Got awarded for timely completion and launching product in Market.