R RAJASEKHAR
Hyderabad
Summary
Seasoned pharmaceutical professional with a robust background in technology transfer and project management, notably at MSN Laboratories. Excelled in formulating injectables and oral solid dosage forms for global markets, leveraging strong documentation and communication skills. Proven track record in enhancing batch execution processes and troubleshooting, demonstrating a significant impact on operational efficiency.
Overview
9
9
years of professional experience
Work History
Junior Manager in Formulation Technology transfer (Injectable)
MSN Laboratories Private Limited
Hyderabad
08.2023 - Current
- Responsible for all technology transfer activity for Injectables of partial process batches, feasibility batches, pre-exhibit (pilot-bio) batches, exhibit batches and new launch commercial batches from R&D to commercial formulation
- Process development for Injectable formulations
- Responsible for preparation of Master BPR's & BMR's and Document Management
- Responsible for various CFT (Cross functional team ) RA, QA, WHD, QC and Engg dept's
- Execution of scale up and Exhibit batches reviewing the GMP related Documents
- Responsible for to initiate change controls due to revision in BMR/BPR and other PD related changes
- To study CPP's & CQA's during scaleup batches to optimize
- Provide the input related batch size process feasibility & process parameters as per requirement
- Responsible for analyze difference between equipment design, capacities, occupancy for batch size calculation and provide batch size proposal to R&D and customer for new product execution at plant
Sr.Executive
Shilpa Medicare Limited
Unit-IV
04.2018 - 07.2023
- Formulation and process development as per QbD concept
- Responsible for all technology transfer activity of partial process batches, feasibility batches, pre-exhibit (pilot-bio) batches, exhibit batches and new launch commercial batches from R&D and customer
- Handling of the customer projects since from the beginning of the project to filing of the product
- Responsible for analyze difference between equipment design, capacities, occupancy for batch size calculation and provide batch size proposal to R&D and customer for new product execution at plant
- Provide RM BOM, PM BOM, tool drawings and packing change parts to PPIC for procurement of new product
- Review&preparation (OSD & Injectables) of Master Documents like MFC, MPC, Packing note, Sampling protocols, Stability protocols, Specifications and STPs, required for product transfers from R&D and customer
- Preparation and approval of plant documents like BMRs, process validation protocols and reports, Stability protocols, Specifications, STPs and other product related documents
- Preparation of feasibility batch protocols and feasibility batch reports after the execution of the feasibility batches
- Preparation of pre-Exhibit batch protocols and process validation reports after the execution of the pre-Exhibit batches
- Ensuring the availability of all Raw and packing materials before the execution of batches
- Completing and submitting the product information and new product execution check list to QA department
- Shop floor execution monitoring and provide technical inputs on trouble shooting during development & manufacturing
- Initiating, approving and closure of the non-conformity for feasibility batches and pre-Exhibit batches
- Initiating, approving and closure of all QMS activities and find out the Root cause Analysis (RCA) and develop corrective action under the guidance of the Dept HOD
- Preparation of investigation reports on deviations / incidents and non-conformity issues by performing laboratory experiments for all batches
- Supporting in trouble shooting and OSS investigations during transfer; revision of master documents and process validations in order to enable smooth product transfer
- Responsible to generate the new material, SFG and FG code for customer projects by coordinating with DQA department
- Individual lead for project management from the formulation development to filing to regulatory agencies
- Managing the third party operations of the projects
- Facilitating the alignment, maintenance and execution of the projects in concrete accordance with overall third party operations
- (CMO)
Executive
Auribindo Pharma Limited
06.2015 - 03.2017
- Responsibility is the ensuring the shift level activities in Granulation area, Roll compactor and Top spray by PAM GLAT 250 FBP, shejong compression machine (61 station) Kevin tablet coater and gansons RMG and FBD, Matcon BIN blending
- Preparation of weekly plans for execution, shift schedules of department
- Significant Accomplishments: Wide spread experience of oral solid dosage forms like tablets, capsules, of general and oncology products, execution at production shop floor for regulatory market like USA, EUROPE, CANADA, ROW, WHO and 3rd party manufacturing purpose
Education
Master in pharmacy -
JNTU-A
Tirupathi11-2016
Bachelor of pharmacy -
Andhra University
Rajahmundry08-2012
Intermediate -
A.K.V.K Jr College
Ongole03-2006
S.S.C -
K.Y.G.H
Maddipadu03-2004
Skills
- Technology Transfer
- MS Office
- Excel
- PPT
- Good Communicator
- SAP
- LIMS
- Documentation
- QMS
- DMS
- Batch Execution
- Troubleshooting
- CMO
- Project Management
- Gap Analysis
Personal Information
- Date of Birth: 05/15/88
- Marital Status: Married
Languages
- Telugu
- Hindi
- Kannada
- English
Industrypreference
Technology Transfer (PDL & MSAT)
Customsection
Wide spread experience of oral solid dosage forms like Tablets, capsules And Injectables (liquid dosage forms) of general and oncology products. CMO projects.
Timeline
Junior Manager in Formulation Technology transfer (Injectable)
MSN Laboratories Private Limited
08.2023 - Current
Sr.Executive
Shilpa Medicare Limited
04.2018 - 07.2023
Executive
Auribindo Pharma Limited
06.2015 - 03.2017
Master in pharmacy -
JNTU-A
Bachelor of pharmacy -
Andhra University
Intermediate -
A.K.V.K Jr College
S.S.C -
K.Y.G.H
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