I completed my B.Tech in Electrical & Electronics Engineering, which provided me with a strong foundation in technical and analytical skills. Currently, I am working as a Senior Executive at M/S Wallace Pharmaceutical Pvt. Ltd. in Nalagarh, Himachal Pradesh.In my role, I have gained extensive experience in the pharmaceutical industry, specifically in both formulation and Active Pharmaceutical Ingredients (API). My responsibilities have allowed me to develop a deep understanding of various critical functions, including:HVAC Systems: Managing and maintaining Heating, Ventilation, and Air Conditioning systems to ensure optimal environmental conditions for pharmaceutical production.Quality Management Systems (QMS): Implementing and overseeing quality management protocols to maintain high standards of product quality and compliance.Computer System Validation (CSV): Ensuring that computer systems used in the manufacturing process meet regulatory requirements and function as intended.Building Management Systems (BMS): Overseeing the integration and operation of automated systems that control the building’s environment.Water Systems: Handling the generation and distribution of purified water, which is crucial for pharmaceutical processes.Additionally, I am proficient in using various electronic documentation and management systems, such as eDMS, eTMS, Synbuf, SAP S/4 HANA, Ample Logic, Trackwise, and Alkemites. These tools are essential for maintaining accurate records and ensuring regulatory compliance.My role also involves plant maintenance, equipment qualification, and validation processes, including Programmable Logic Controller (PLC) validation and HVAC validation or revalidation. I am skilled in vendor management, capital expenditure (CAPEX) planning, budgeting, and the preparation of Standard Operating Procedures (SOPs) and other relevant documents.Throughout my career, I have worked in regulatory-approved facilities and have successfully participated in inspections by various international regulatory bodies, including:US FDA (United States Food and Drug Administration)WHO (World Health Organization)MHRA (Medicines and Healthcare products Regulatory Agency, UK)TGA (Therapeutic Goods Administration, Australia)ANVISA (National Health Surveillance Agency, Brazil)MCC (Medicines Control Council, South Africa)PMDA (Pharmaceuticals and Medical Devices Agency, Japan)EU (European Union)KFDA (Korea Food and Drug Administration)
Listed skills include Engineering, Management, Hvac, Qms, and 1 others.
