Sudhir Thube Email & Phone Number

Pune Area, India

Pune Area, India

Mumbai Area, India

An energetic professional with 33 yrs of experience in handling operations of a complete API Unit along with global regulatory experience (like USFDA, MHRA, EDQM, ISO 14001 & OHSAS 18001) in the Pharmaceutical industry, with area of expertise on,Conceptualizing and planning strategic objectives after detailed analysis, setting of long term goals with road maps. timelines and implementation strategies.Implementing systems and processes to monitor and report on performance based on Key… Show more An energetic professional with 33 yrs of experience in handling operations of a complete API Unit along with global regulatory experience (like USFDA, MHRA, EDQM, ISO 14001 & OHSAS 18001) in the Pharmaceutical industry, with area of expertise on,Conceptualizing and planning strategic objectives after detailed analysis, setting of long term goals with road maps. timelines and implementation strategies.Implementing systems and processes to monitor and report on performance based on Key Performance Indicators with midcourse reviews and performance assessments. Prepare, plan and coordinate project schedules to ensure timely and correct execution along with creating and establishing facility qualification documents.Decisive and forward thinking with strong vision, ability to network and liaise at appropriate levels for quick implementation of processes.Carrying firm belief in system orientation. Dedicated to maintaining high quality standards. Able to build a well esteemed productive team. Having strength and proven leadership skills to achieve the objectives with sincerity and honesty through people with equal emphasis on tasks and to convert the resources into products with high quality standards for achieving the profitabilitySpecialties:API-Pharmaceutical Operations Show less

Mumbai Area, India

Functional Competance :•Finance /Marketing Support (At Corporate level)a) Identifying opportunities in regulatory market and checking domestic competition and preparing strategies for sustainability and business continuity plan •Manufacturing a) Usage of optimum manpower,and… Show more Functional Competance :•Finance /Marketing Support (At Corporate level)a) Identifying opportunities in regulatory market and checking domestic competition and preparing strategies for sustainability and business continuity plan •Manufacturing a) Usage of optimum manpower,and equipments for achieving material conversion into products b) Scale up, process validations, and commercialization of new API's c) Solvent Management for recoveries and improvements •Regulatory Affairs and Quality Assurance at corporate and operations level •Process Development a) Monitoring the progress of synthesis of new products. /Scale up /Technology Transfer.b)Impurity synthesis and characterization (inhouse as well as from external agencies) c) Cost reduction measures •Engineering a) Monitoring preventive and project activities b) Preparation of Capital expenditure plans, approval •Inventory Control &Vendor Devlopement •Safety ,Health& Environment a)Ensuring the compliance of safety norms in manufacturing areas / laboratories/Warehouses b)Carrying out Risk analysis at various stages in product devlopement c)Accident and dangerous occurrence analysis. d)ETP Plant Management .to keep generated effluent within operating criteria e)People safety/Product safety f) Training of personnel Show less