ROHIT SHINDE

Manufacturing Management :

· Manufacturing Operations Project Management & Coordination with Lupin Manufacturing sites & Corporate Office.

· Responsible for Technical Services function at Lupin for technical support and Coordination with Lupin sites for Japan Business.

· Project management and Technical supports with specific focus on technology transfer from/to overseas sites & manufacturing management of Japan products at various sites.

· Working closely with other organizational functions like Manufacturing Sites, R&D, PD Labs, Technology Transfer Team, Supply Chain , Procurement , Regulatory Affairs, Business Finance Group, Business Development Team , Analytical R&D, Site Quality Departments & CA and other external vendors and external organizations and In- Country Care Taker (ICC),Japan Manufacturing Management

· Organizing monthly production meetings & yearly manufacturing operations review meetings, MTP (Medium-term Plans) & CAPEX review meetings of site heads with management team.

· Coordination with manufacturing sites daily, weekly, monthly basis on various issues.

Technical Services :

· Project management and tracking of Japan development transfer, site transfer projects as per the timelines.

· Monitoring, tracking manufacturing & supply of Japan commercial products at Lupin manufacturing sites.

· Coordination with Japan IC, Marketing authorizations holders and Japanese customers for technical matters like change control & deviation approvals, investigations, GQP agreements.

· Conducting weekly /monthly meetings between work groups to review the project progress and resolve the issues.

· Preparing monthly reports on Japan development, site transfer and commercial products and updating progress to the senior management.

· Coordination with Regulatory Team, Japanese IC, MAh, Customers for timely submissions / filings of API J-DMF, amendments, Formulation New Products submission & Site transfer product filing, PA/MCA variation filing for Japan Market.

Coordination with ICC, MAh & Lupin manufacturing sites for PMDA & Japanese MAs GMP inspection.

· Yearly monthly planning and scheduling of development transfer, site transfer and alternated API vendor development projects.

· Project management for overseas site transfer (JAPAN, US , EUROPE, MALAYSIA, INDONESIA, KOREA , MEXICO AND SOUTH AFRICA ) & internal site transfers.

· Responsible for Alternate API vendor development projects for existing commercial projects

· Responsible for technical support for technology transfer projects

· Co-ordination and tracking of all technology transfer projects

· Harmonization of technology transfer process to all manufacturing sites

· Quality & regulatory (New Product registration, FMA accreditation, Site GMP compliance inspection) support for Japan Market

Highlights:

· Expertise for Japan, Malaysia, and Indonesia & US Market for development & site technology transfer products.

· Successfully launched & commercialized more than 30 products from Indian Manufacturing sites for Japan Market

· Outsourced /Alternate API source Development for all products (US,EU, AUS and Japan market).

· Project Management for Reformulation, Site transfer & Development Transfer Projects.

· Responsible for Reformulation & COG's improvement projects.

· Yearly ,monthly and weekly planning and scheduling of Reformulation , Site Transfer & Development Transfer Projects

· Change request initiation and closure of all Reformulation Projects.

· Preparation of cost vs. benefit analysis sheet for all Reformulation Projects. Preparation of business case study for all Reformulation Projects.

· Review of Technical Document Package (TTP) and dossiers of formulation

· Preparation and review of documents like Reformulation Protocols, Quality Risk analysis reports, scale up reports, Technology Transfer Protocols, Reformulation Product Reports, and Technology Transfer Reports.

· Working with formulation & development department, finalizing the formulations
by overcoming the problems involved in it, reviewing stability data, taking scale-up batches ,working with product registration dept. ,communication and follow-up with R & D and PRC to set the products.

· Ensuring product compliance, procedures and processes at third party manufacturer with regulation and guideline through auditing and feedback.

· Execution of validation batches within agreed timeline.

· Manufacturing of scale up batches for formulation optimization.

· Support to regulatory functions for providing data for regulatory submissions, handling of product quality defects respectively.

· Handling product complaints and quality defects, OOS and subsequently improved quality of Products.

· Active team member of ANDA/NDA projects , Working with formulation & development department, finalizing the formulations by overcoming the problems involved in it, reviewing stability data, taking scale-up & trial batches ,validation batches & Launch batches.

· Played key role for technology transfer of tablets from European/Australian manufacturing sites to Indian manufacturing sites to achieve consistent quality in accordance to European and other regulatory guidelines.

· Played key role to undertake key studies associated with the 'product, formulation, manufacturing process and troubleshooting.

· Preparation of performance reports for new products considering all its physical and analytical parameters, stability data and final pack representation. Tech-Mar study (comparative study with competitor brands.

· Considering physical and analytical parameters) of new products. Preparation and updation of the product history files. Preparation of various daily documents related to routine procedures and manufacturing according to SOP's.

Responsible for:

· Coordination with packing for planning & scheduling yearly, quarterly, weekly capacities, production targets.

· Execution of targets by proper & dynamic coordination with packing, stores, QC, QA& Engineering department.

· Generation of Monthly Report & Yield Statements.

· Qualification of new equipment, requalification of old equipment.

· Implementation of cGMP for Quality Production

· Up gradation of SOP's, Formats & Designed New documents as per global quality standards.

· Supervision of day-to-day activities like dispensing, granulation, compression, Coating etc. In-process controls, Rejection Controls in order to improve yields.

· Played key role to achieve production demands with consistent quality besides manpower handling.

· New plant set up at different unit for tablets departments for equipment installation, qualification, validation and its subsequently smooth functioning to achieve quality of product with reproducibility and technology transfer for tablets from one unit to other Unit.