Amit Sharma Email and Phone Number

To Implement cGMP, cGLP, cGDP, cCLP principles and maintain Quality standards, validation and documentations related to the dosage forms produced by the Company i.e. LVP-SVP Liquid, Dry powder & Lyophilised Injections, Oral Solid dosages ie. Tablets, Capsule (Hard & Soft Gelatin), Effervesent Tablets, Creams and Ointements, Oral Strips, Liquids, Pouches form and Neutraceuticals formulations.1. Fully responsible for overseeing the functioning of the entire Factory operations & provide a full comprehensive MIS to the management related to own Production, Outsourcing and Contract manufacturing.2. Manage and guide all department process owners and through them all other supporting managers, Asst. Manager, Supervisors and supporting staff etc.3. Managing the entire gamut of tasks related to Factory Operations, Administration, Raw Material /PM/Primary & Secondary Packaging Material/Diluents (WFI, NACl, Sod. Bicarbonate), Incoming Stocks outgoing dispatch, Production, Planning and Control, Order execution, Quality Control and Quality Assurance, Purchase, Manpower & Labour, Security & Safety all day to day tasks.4. To manage and improve Plant efficiency in all interlinked Production, Operation, Inventory, Quality etc.5. Suggest improvement for increasing profitability of entire business & operations.6. Meeting the supply order of the client and keeping coordination.7. Plan organize and direct the manufacturing and maintenance operation which ensures the most effective return on assets.8. Initiative plans and processes which minimize manufacturing costs through effective utilization of manpower, equipment facilities, materials and capital. 9. Assure attainment of business objectives and productions schedule while insuring product standards that are mandatory.10. Encourage use of new techniques and focus on fact based problem solving.11. Improve manpower utilization within existing departments and processes. Schedule stability that allows for maximum efficiencies.

To lead the Quality Control, Quality Assurance, Health & Safety functions and drive Continuos Improvement, Operational Excellence and various cost savings projects across the business. Identify gaps in the current system and work closely with cross functional teams for system improvement by modifications in equipment, process flow, working practices, etc. Act as a Change agent to instil problem solving and continuous improvement culture in the company. Enforce the practical implementation of above methodologies with the help of small projects, case studies by training, retraining the HOD’s and their downline people. Improve the current Quality Management System including development / improvement of procedures and SOPs to ensure compliance and enhanced customer satisfaction and achievement of ISO 18000 going forward. Ensure whatever is being produced in the business meets and exceeds customer's expectation in every aspect. Drive and lead Statutory and Regulatory Quality Compliance. The maintenance of an effective Quality Management System aligned to recognized best industry practice that demonstrates continuous improvement. Drive OQ/PQ/DQ/IQ improvements, Identifying losses and facilitating Loss Reduction Projects, Reduce Breakdowns and Maintenance Cost, Reduce Energy Consumption by improving Utilities etc.

To Plan patent non-infringing developmental strategies for US/EU markets for products identified from time to time. To plan, and supervise pre-formulation, formulation, and process development activities related to the filings. To review and execute documentation related to product development and technology transfer. To provide assistance in liaison with Plant and Regulatory for product related activity To provide assistance in planning, and review of formulation Scale-up and technology transfer. To ensure compliance to cGMP and Standard Operating Procedures and maintenance and revision of SOP’s/STP's/Logbooks being utilized in all operational activities. To assist in Budget preparation, employee engagement, team development and planning and logisticsResponsible for overseeing and managing a continous improvement project schedule for the operations group including improvement, expansion and diversification projects.Responsible for providing direction for project lifecycle management and evaluating project planning, execution, performance, scope and providing regular reports on cost, schedule and risk.Communicates with business customers and management to provide reports on budget, cost, schedule, risk goals and priorities for projects.Provides technical expertise and support for the manufacturing and packaging operations.Develops project plans and identifies tracks and coordinates task between various functional areas to implement projects.Review, Researches and analyzes data related to manufacturing and packaging operations to suggest improvements and promote efficiency.Generates and / or modifies standard operating procedures, batch records, special instructions and other related manufacturing and packaging documentation as specific to associated projects.Completes appropriate documentation to support project tracking, implementation and change management..

Good understanding of various aspects of QA and analytical techniques. A progressive and dynamic professional in the Pharmaceutical Industry with rich functional expertise in analytical method development, validation, chemical testing, managing stability programs, protocol/report reviews and regulatory compliance.To prepare and review all the department the SOP’s related to Production / Packaging / Utility / Administration / Stores area. To ensure appropriate validation activity of the production. To ensure production / packaging as per cGMP. To keep control on the consumables Reviews of batch manufacturing records & related documents. Ensure that product are produced and stored as per the SOP managing the required quality standard. Review and comply an audit points. Monitoring and controlling the yield losses during production process. Planning & monitoring of preventive maintenance schedule of the equipment with Engineering.Imparting and verifying on the job training to subordinates and technicians ad per the need. Preparation of daily production reports. Ensure stage wise Boor entries for all production process. Facilitate PDL/DRA for manufactories Exhibit batches. Ensure tooling / change part availability for products at various process stages. On line completion and reviewing of the batch packaging records and documents. Monitoring and controlling the yield losses during the packaging process.