Shivkumar Dangi

About Shivkumar Dangi

Responsible and accountable for quality assurance functions at site.1.0 QUALITY COMPLIANCE AND SYSTEM:1.1 DOCUMENTATION1.1.1 To ensure online documentation related to current good manufacturing practices (cGMP).1.1.2 Continuous improvement, review and approval for upgrading existing SOP’s, quality policy and system with respect to compliance to global standards.1.1.3 Responsible for singing the documents as a role (checker, reviewer, verifier, approver) Batch Records, conversion note, stability protocol and reports, Product Quality Review, additional material requisition, BMR & BPR pages initiation and approval, analytical data COA reviewed and print, Standard operating procedure, material destruction note, trend charts, logbooks, out of specification/out of trend, calibration planner, line rejection note verified, continued process verification, good issue request, Validation and qualification protocol and reports, Organogram etc.1.2 QUALITY MANAGEMENT SYSTEM1.2.1 To ensure and participate in the procedural deviation or any failures, out-of-specification, complaints, recalls, returned products and out-of-trend are appropriately investigated with risk assessment and documented. To ensure appropriate corrective actions and preventive actions are proposed and implemented based on the outcome of the investigation.1.2.4 Ensure and monitor the source of materials, manufacturing and testing of products is carried out as per registered marketing authorization.1.2.5 To coordinate and participate during all customer/regulatory audits and monitor compliance to audit observation and cGMP requirement.2.0 QUALITY OPERATIONS2.1 Responsible for execution for shop floor QA activities2.2 Ensure that all the requirements of APQR are fulfilled, identified recommendations of APQR shall be implement through QMS tool and tracking will be done through CAPA, 2.3 Responsible to perform & review of calibration/verification as per schedule.2.4 Ensure the collection and submission of QC, stability, control and others samples.2.5 Responsible to initiation and evaluation of work order/ work permit.2.6 To participate for review and approved for IT related activities as and when required software’s application.2.7 Responsible to perform & ensure the area and equipment line clearance, In-process checks of all operation regarding the manufacturing and packing.2.9 Responsible to perform audit trail and operation of software like e-DMS, e-LIMS, e-logbook, e-LIMS and Q-sutra etc.2.10 responsible to handle Quality related issues at shop floor level.

Experience

1. Quality Assurance Officer

   Lupin

   Dec 2024 — Present · Mandideep, IN

Education

• Sagar Institute of Pharmaceutical Sciences, Sironja, Infront of Jubilee Petrol Pump, NH-26, Narsinghpur Road, Sagar-470004

  Bachelor of Pharmacy - BPharm

  2018 — 2022