Kuldeep Dandotiya
Senior OSD Production Leader- End to End Manufecturing/Packing operation|20 Years Experience in Granulation,Compression, Coating & Packing |Track & Trace |Leading 550 Mio/Month| USFDA,EMA,MHRA,WHO GMP Compliance Expert.
- Role
- Assitant General Manager at Viatris
- Location
- Indore, IN
- LinkedIn followers
- 500 followers
About Kuldeep Dandotiya
Lead end-to-end Oral Solid Dosage (OSD) operations covering…
Experience
Assitant General Manager
Mar 2022 — Present · Indore, IN
Lead end-to-end Oral Solid Dosage (OSD) operations covering Granulation,Compression, Coating, Inspection & Packing.Ensuring compliance with cGMP, GDP, EHS, and international regulatory bodies — USFDA,EMA, MHRA, WHO, MoH-Belarus.Driving production planning and execution to meet monthly and daily targets as per businessrequirements.Managing SAP-based online documentation ensuring accuracy, traceability, and data integrity.Reviewing & approving BMRs, SOPs, URS, PRs, validation and qualification documents forregulatory compliance.Overseeing QMS activities including CAPA, deviations, investigations, and change controls through Track-wise / D2.Leading process validation and commercial batch execution ensuring audit readiness andcompliance.Collaborating with QA, QC, Engineering, PPC, SCM, WH, and EHS for smooth plant operationsand issue resolution.Achieving consistent improvement in OEE, yield, and throughput via data-driven performance monitoring.Implementing Lean Manufacturing, Six Sigma, Kaizen, and 6S initiatives to drive operational excellence.Managing technology transfer and scale-up from R&D to commercial production ensuringseamless execution.Conducting cGMP, GDP, SOP, and safety training to enhance workforce competency and compliance culture.Optimizing manpower deployment, shift planning, and resource utilization for productivity enhancement.Ensuring robust Good Documentation Practices (GDP) and maintaining regulatory audit readiness Track-wise, D2 System, Glams, EMS and Track and trace serialisation and palatalisation.Supporting troubleshooting, root cause analysis, and CAPA implementation for process andproduct deviations.Leading continuous improvement projects focused on reducing cycle time, energy use, and processwaste.
Education
M.P. Board Bhopal
High school
1997 — 2000
Jiwaji University (JU), Gwalior
Bachelor of Pharmacy - BPharm
2001 — 2005
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