Rajkumar Gupta
Senior Manager-(Production Head), API Manufacturing & Speciality Chemicals, DCS experiance, scaleup, Multiproduct plant handling, MBA- Operation Management, Six Sigma- IIT Kharagpur, Lead Auditor for ISO 9001:2015 - DNV.
- Role
- Senior Manager - Production at SPC Lifesciences Limited
- Location
- Bharuch, GJ, IN
- LinkedIn followers
- 500 followers
About Rajkumar Gupta
Pharma & Speciality Chemical manufacturing professional with a Global Regulatory 17.0…
Experience
Senior Manager - Production
Sep 2024 — Present
Technical: Responsible for monthly production target, production planning and yield & quality of product. Responsible for smooth plant operation by concerning with respective department. RM planning, inventory and stock maintaining as per production planning. Manpower management, shift instructions / information communication. Responsible for Technology transfer received of new molecules from R&D/PD to MPP plant with better technical support. Prepare Batch Manufacturing Record from R&D TTD report followed by Change management, MOC, HAZZOP & PSSR. Plan Process Validation by preparing Process Validation Protocol & Report then preparing Optimization report cum Technology Transfer report to permanent trial batches experience. Support team in plant routine troubleshooting by taking loop to R&D, PD, Safety and plant HOD.Quality Management System: Ensure timely initiation and closure of all the QMS activity (Change control, Deviation, OOS, OOT, CAPA, market complain, QRM etc.). Ensure implementation of IMS (ISO: 9001, 14001 & 48001) and ready for IMS & GMP audits. Plant readiness for Audits (Regulatory & Customer) and ensure 100% technical training of shop floor. Preparation of Investigation Report for various Non-Conformities like Deviation/OOS/OOT/Return Goods/Market Complain/Quality variation during Quality Evaluation. Preparing Quality Risk Assessment (QRM) for all Products and system. Equipment Qualification during plant commissioning & expansion followed by URS/DQ/IQ/OQ.Process Safety: Taking part in HAZZOP meeting and ensure all the recommendation given by safety department are complies (Engineering & Administrative both). Taking part in PSSR before startup of new campaign. Filled the MOC (Management of Change) for all changes in plant and ensure its timely closure.
Education
Veer Bahadur Singh Purvanchal University, Jaunpur
BSc. (Industrial Chemistry), Mathematics, Chemistry & Industrial Chemistry
2003 — 2006
Mahatma Gandhi Chitrakoot Gramodaya Vishwavidyalaya
MSc. Industrial Chemistry , Basic Chemical Engineering & Advance Manufacturing
2007 — 2009
NIMS - National Institute Of Management Solutions
MBA (Operation Management), Operations Management and Supervision
2013 — 2015
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