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Punit Tiwari

Production Officer

๐Ÿ‡ฎ๐Ÿ‡ณVapi, Indiaยท1.5 years experience
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About

Punit Tiwari is a production professional with 1.5+ years of experience in GMP/QMS-regulated medical device manufacturing. He possesses expertise in production execution, batch documentation, deviation/CAPA handling, equipment coordination, and audit readiness within an ISO 13485-aligned environment. He is adept at managing QMS documentation, coordinating with cross-functional teams for process optimization, and ensuring regulatory compliance. He is seeking opportunities to leverage his skills in a dynamic production role within the medical device industry.

Experience

Production Officer and End-User โ€“ Endosurgery Vertical

Dec 2025 โ€“ Present ยท 10 mos

Meril Life Sciences Pvt. Ltd. ยท Vapi, Gujarat

  • โ€“Executed production operations for sutures and surgical needles in a cGMP environment.
  • โ€“Managed QMS documentation, including E-BMR, deviations, change controls, and CAPA.
  • โ€“Coordinated with QA, QC, and Engineering for deviation closure and process optimization.

Production Officer and End-User โ€“ Molecular Diagnostics

Jan 2025 โ€“ Dec 2025 ยท 11 mos

Molbio Diagnostics Ltd. ยท Goa, India

  • โ€“Manufactured PCR-based molecular diagnostic kits in compliance with GMP.
  • โ€“Maintained BMRs, SOPs, and deviation reports for good documentation practices.
  • โ€“Performed reagent preparation, equipment calibration, and batch monitoring.

Skills

ERP & Supply Chain

SAP S/4HANA MMProcure-to-Pay (P2P) CyclePR/PO ProcessingGoods Receipt/Issue (MIGO)Invoice Verification (MIRO)Inventory & Material ManagementBatch Tracking

Quality & Compliance

GMP/cGMPISO 13485:2016-aligned QMSQMS DocumentationGood Documentation Practices (GDP)CAPADeviation & Change ControlSOP/WI AdherenceAudit ReadinessRCA/5-Why Analysis

Production & Operations

Batch Manufacturing Records (BMR/E-BMR)Lean Manufacturing & Continuous ImprovementShift PlanningManpower Allocation
GMP/cGMPISO 13485:2016QMS DocumentationCAPASAP S/4HANA MMBatch Manufacturing Records

Languages

English (Fluent)

Education & Certifications

B.Sc. in Biotechnology

Patliputra University ยท 2025

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