Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, India with over $2.8B USD turnover. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology product• As Engineering Head, am responsible for end-to-end engineering operations of Biologics which… Show more Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, India with over $2.8B USD turnover. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology product• As Engineering Head, am responsible for end-to-end engineering operations of Biologics which constitutes Cell culture manufacturing, Fill-Finish facilities, Research & Developmental facilities, and oversight of Utility Operations. In this role, have successfully improved engineering systems through restructuring, improved Quality compliance and Statutory actions, redefined SME roles, improved SHE metrics, improved inventory controls via initiatives, upgraded efficiencies of engineering equipment & infrastructure. Successfully led engineering through two major regulatory audits – FDA & EMA.• As Projects Head: am responsible for driving strategic initiatives, ensuring successful and timely execution of key projects. In this role, have identified system lags, optimized resource allocations & key dependencies, limited scope & cost creep, actively engaged stakeholders, addressed technology – skills – resource limitations to enable project success. Show less

• Oversight of engineering operations for oral solid dosage facility, execution of projects on building new facilities including process optimization and capacity enhancements. • Provided engineering leadership for construction of 2 plants - a 33000 sq ft facility for Injectable API and a 54000 sq ft facility for Quality Control and R&D laboratories.• Ensured continuous improvements & engineering excellence for sterile complex. KPIs design for department and team performance, follow up… Show more • Oversight of engineering operations for oral solid dosage facility, execution of projects on building new facilities including process optimization and capacity enhancements. • Provided engineering leadership for construction of 2 plants - a 33000 sq ft facility for Injectable API and a 54000 sq ft facility for Quality Control and R&D laboratories.• Ensured continuous improvements & engineering excellence for sterile complex. KPIs design for department and team performance, follow up of objectives and targets.Key Accomplishments: • Documentation and Audits: This has been a key area of my contribution towards laying in systems for Equipment – Facility qualification, validation, preparation of SOP’s, CAPA, methods of handling deviations and their controls. Also, have been a lead auditee for the engineering department for Regulatory, Customer and Certification audits. Have faced many audits directed towards facility and products from USFDA, MCC, TGA, ANVISA, JFDA etc. Also function as a internal auditor for the department.• Energy management- Introduced a system of continual focus on energy management by linking it to objectives, evaluation of individual’s performance based on achievement of objectives. Sphere headed multiple Energy management programs on black utility, clean utility and direct energy savings.• Green initiatives: ODS management schemes, Rain water harvesting, waste reduction and effective treatments, various kinds of waste management systems and working on Carbon credits scheme. • Coordination for Continual improvement programs on TQM, Kaizen, GEP, active member of quality circle, trainings of personnel, chalking induction and job orientation programs for new recruits. • Engineering analysis on equipment – decision of replacement, downtime, MTTR, MTBF, Plant uptime analysis, condition monitoring for equipment, predictive analysis. Show less

Biocon Sdn Bhd is Asia's largest integrated Insulins manufacturing facility and is Biocon’s first overseas bio-pharma manufacturing and research facility located within a 40 acre compound, at Bio-XCell, Johor in Malaysia, the new regional biotech hub of Asia that offers a state-of-the-art biotechnology ecosystem. The facility is the largest integrated insulin production plant in Asia, with an investment of over USD 200 million.• As Director for Engineering and EHS services, my role was to… Show more Biocon Sdn Bhd is Asia's largest integrated Insulins manufacturing facility and is Biocon’s first overseas bio-pharma manufacturing and research facility located within a 40 acre compound, at Bio-XCell, Johor in Malaysia, the new regional biotech hub of Asia that offers a state-of-the-art biotechnology ecosystem. The facility is the largest integrated insulin production plant in Asia, with an investment of over USD 200 million.• As Director for Engineering and EHS services, my role was to take the plant from a project stage and set up engineering & safety systems that meet regulatory requirement. I established a frame work for both functions and built a team of 90+ engineers to execute the facility project and ensure continued successful plant operations. • Presented project status to Engineering leadership during function reviews, and to Site Leadership on behalf of Engineering.• Ensured validation and regulatory status of the plants and equipment as per applicable regulatory rules and successfully led Engineering through multiple audits by regulatory agencies.• Led development of training modules for the department & imparting trainings on GEP, cGMP, OHSAS & SAP.• Ensured a healthy quality system exists by reduction in engineering related deviations, avoidance of repeat failures.• Developed revenue budgets for maintenance & improvements. Tracked CAPEX and OPEX budgets utilization.• Implemented Grey / Green field projects as required, involved in process optimization, plant / equipment upgradation, projects on energy conservation.• Set up systems for pest management, chemical hazard identification CHRA, Hazop studies, annual health monitoring, first aid and emergency squad, waste management for scheduled wastes, accident / incident reporting – tracking – investigations – Controls, Training on EHS, Setting up EHS management systems and Safety systems as per local guideline. Show less

As an executive to Sr manager my roles were :• Supported multiple small to large scale projects on Biologics processing with upstream fermentation process to downstream processing, fill-finish and packaging operations. • Worked on small to large scale projects on fermentation upstream and downstream processes, lab facilities, injectable API’s, parental plants, warehouse, clean utilities, water generation and distribution systems and energy management programs.

Projects and maintenance of Hygroscopic products manufacturing, involving Rh below 25% in the entire facility. Project involved installation of a high end HVAC system, equipments for manufacturing and packing.Experience on Cytotoxic product handling facility that laid high emphasis on personnel protection involving working under reverse flow LAF’s, Compressed air suits, isolation barriers, vacuum transfer systems and like equipments.Experience in chemical synthesis facility that… Show more Projects and maintenance of Hygroscopic products manufacturing, involving Rh below 25% in the entire facility. Project involved installation of a high end HVAC system, equipments for manufacturing and packing.Experience on Cytotoxic product handling facility that laid high emphasis on personnel protection involving working under reverse flow LAF’s, Compressed air suits, isolation barriers, vacuum transfer systems and like equipments.Experience in chemical synthesis facility that involved installation and commissioning of Reactors, Centrifuges, filters, Dryers, and all process Equipment and Process pumps in synthesis-3 plantExperience in a tablet manufacturing unit that handled multi product formulations to blending – drying – compression – coating – blister packing.Experience in soft gel capsule manufacturing consisting of formulation – drying – filling – de-dusting – polishing – sorting – blister packing Show less

Himalaya Drug Co. is a leading herbal healthcare company, with a mission to satisfy each customer's heath needs through well-researched, effective and safe remedies harnessed from nature's wealthWas exposed to various facilities on Formulations and packaging of Herbal products in liquid and solid dosage forms - Soft gel capsule handling – ophthalmic and cosmetic products.