Ref. No. : CA - 37114 - (Quality - Injection Moulding – with 3.3 years in Plastic Industry)

Education

B.tech From Central Institute of Petrochemicals Engineering and Technology, Dr. A P J Abdul Kalam Technical University, 2021

Intermediate From S.B.L. Kamla Puri IC Gonda UP Board Year 2015

High School From M.P.S.K. I.C. Gonda UP Board Year 2013

Skill Sets

MS Office ,( Excel, Word, Power Point ) , Auto CAD
ISO Standards, Testing, Audit Documentation and Calibrations, Process failure mode and effect Analysis (PFMEA)

Work Experience

Designation : Jr. Engineer In Quality Control
From : Jan 2022 till date
Company Profile : Manufactures and assembles plastic products for healthcare, consumer, personal care and automotive and engineering

Job Profile :
Expertise in development of device test methods and preparation of test protocol, test reports, Design verification documents, and work instruction in line with user needs and design inputs.
Knowledge of different testing method of Drug Device Combination Products like self Administration Injection Systems (NIS) such as Pen injector.
NPD prototyping of sample, static and dynamic Testing failure analysis to meet ISO 11608: 2022 Standards.
Calibration and Testing Machine handling throughout several tests- Zwick Roell (UTM), Torque tester, Compressive and tensile test, Digital weighing balance, MFI, Roundness tester.
Process control and optimisation as per IMS policy using various standards and tools -5S, Kaizen, QC tools, Poka-Yoke, Lean Manufacturing.
Documentation of various Test procedures sample preparation, testing, consolidating test results and making inferences.
Inspection & Testing activities IQ/ OQ/ PQ/ assembly/ Pre dispatch inspections and Design Verification testing.
Develop testing and measuring method on customer or standard requirement.
Maintain the quality management system documents including QMS, SOP, Formats, Work instructions policies cover the applicable standards (including ISO 9001, ISO 13485, ISO 11608)
Development of Device test methods
Preparation of test protocol and test Reports, Design verification Documentation (DHF)
Work instruction in line with user needs and design inputs
QMS (Deviation/Exemption , Incident, CAPA)

Future Goals

A Focus Professional With Work Experience Of More Than 2 Years In Medical Device Manufacturing And Primary Packaging Development In Quality Department, Seeking For A Challenging Position Where I Could Make A Significant Contribution By The Virtue Of My Skills And Hard Work

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