Ref. No. : CA - 30220 - (Production - Blow Moulding – with 15.1 years in Plastic Industry)

Education

MBA in (Total Quality Management) from Sikkim Manipal University in January 2011
B.Com from S.R.K. College of Commerce, Dahanu in 2008
Completed CIPET from Aurangabad

Skill Sets

Windows Office
Tally Financial Accounting Package 7.2
Internet Explorer

KEY SKILLS
Production Planning & Plant Management
Material & Resource Management
Quality Standards & Systems Management
Standard Operating Procedure Knowledge
Internal & External Auditing
Customer & Supplier Coordination
Production Process Analysis & Development
Analytical & Managerial Skills
Problem Solving Ability
Good Interpersonal & Communication Skills

Work Experience

MR (Management Representative) / QUALITY ASSURANCE MANAGER /REGULATORY AFFAIRS MANAGER
From JAN 2017 to till date..
Company profile- manufacturing top quality Needles, Trocars, Stylets and Wires as well as Plastic Components

Job profile-
Ensure that Quality Policy is understood, implemented and maintained at all level of organization.
Maintaining quality during manufacturing by ensuring that all work is carried out on the shop floor according to Standard Operating Procedure (SOP)
Develop, implement and revise procedures, files, records, and follow-up systems to ensure processes are managed in a well-organized and timely manner
Monitor and verify qualification and validation of equipment's and tools to ensure compliance to written protocols, and regulatory requirements, as applicable.
Developing and prioritizing an auditing schedule and perform internal quality audits in support of ISO, MDQMS, and GMP Quality System (Lead Audi-tee )
Expediting closure of internal and external audit observations. Assess closure of audit observations for timeliness, completeness of root cause, corrective action and preventive action.
Responsible for preparing equipment protocols for qualification and validation including IQ, and OQ, PQ.
Drive quality system improvements and ensure compliance to regulatory and procedural requirements.

Ensuring ISO 9001:2015 , ISO 13485 :2016 as well GMP requirements are met .
Liaison with external agencies such as Certifying agency, Client, Consultant etc.

Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Responsible for Standardization and Validation of all the instruments, related processes and documentation as well calibration of equipments.
Responsible for control and issue of BMR as well BATCH RELEASE of the Product
Identify Training Need, Competency Assessment, and Training Calendar.
Handling all customer complaints with proper RCA/CAPA/8D/SNCR

Maintaining all Records and Files required for ISO 13485:2016 as well as for GMP like Quality & GmP manual , Internal Audit , MRM Records, SOP
,In-process as well Final batch release plan ,Process Validation, IQ,OQ & PQ Records of machine , Clean Room validation , Cleaning validation records
,Self life stability test record ,External Standard file ,Calibration records ,All HR records like Training , Skill Gap Analysis, Health certificates, etc..

INSTRUMENT ON HANDS :- Penetration test Mc , Pull Strength Mc , Moisture
meter, Refracto-meter , Mitutoyo Quick Scope measuring Mc etc....

Quality Assurance & Project/ Development Manager
From Feb 2015 till Aug 16
Company profile- manufacturing of plastics molding items, manufacturing Lubes, Food & Beverages, Personal Care/House Hold and Pharmaceuticals Components.

Job profile-
Maintaining all extrusion, blow and injection moulding products running under controlled customer specification
Maintaining quality during manufacturing by ensuring that all work is carried out on the shop floor according to Standard Operating Procedure (SOP)
Conducting Internal Audit and Supplier Audit as per scheduled
Physical checking of running production of blow moulding, injection moulding and extrusion blow moulding machine article
Knowledge of ISO 9001 -2008 , FSSC 22000 , BRC , 14 k , 22 k and have faced all the Audits (Lead Auditee)
Upkeep & maintaining lab equipment and their calibration
Analyzing competitor sample and comparing the same for the betterment of quality
Handling all customer complaints with proper RCA/CAPA/8D/SNCR
Maintaining all QC Records (Post shrinkage report, AOQL report and all incoming material report like MFI, ESCR, poly bag, corrugated box etc. and HACCP records as per standard protocol
Worked on project of HUL like 200 ml Surf Excel BIKINI, 200 g GALVANISE, 60 ML MARODONA MEASURING CUP ,
Exposure to ERP System
Handling responsibility for new mould set up and development of same
Conducting employee training, skill gap analysis, and competency of QC officer
Maintaining and upgrading records of audits like ISO 9001, FSSC 22k, BRC &14k
Knowledge of screen printing and pad printing

Instrument Handled
Top Load Machine (Universal Testing Machine)
Melt Flow Index Tester
.ESCR Tester (Oven)
Vacuum Leakage Tester
Colour Cabinet
Non –Destructive wall thickness Tester (magna mike)
Vernier/Micrometer/Height guage
Drop Tester

Quality Assurance/ Quality Control Head
From May 2008 to 2015
M/S RAJIV PLASTICS INDUSTRIES
Job profile-
All Injection & Blow molded – products, running under controlled customer specified specifications and as per company’s described SOP’s

Physical checking of all parameters in mould approval stage
Commission on new mould sample as per customer specs & necessary changes required
Checking incoming goods to pre dispatch and final dispatch on daily basis
Maintaining all Q.C. formats required for ISO Audit
New development of packing material like polybags of various sizes, corrugated boxes, blister caps etc.
Conducting vendor audit
Attending customer complaint, finding RCA & doing correction, corrective and preventive actions accordingly
Coordinating with MR for ISO
Conducting employee training and competency

As Food Safety Manager
Conducting food safety internal audit & training every six month and maintaining all records required for food safety audit
Preparing housekeeping schedule and verifying record
Maintaining personal hygiene record and pest control verification record
Waste and sewage disposal verification record
Maintaining production & storage verification record
Other
Preparing production log book in the absence of production in-charge
Maintaining production raw material & master batch (colour) issue and receipt

PROJECT
Title: Implementation of Total Quality Management in Rajiv Plastics Ind., Umbergaon
Overview
My profile contains quality of production at18 CMP Blow Moulding & 2 fully Auto Deflash Machine and with 3 Injection Moulding Machine. Our Esteemed Clients in Lubes Oils are like: IOCL, HPCL, BPCL, HUL, VALVOLINE, SHELL RAJ – PETRO, BOSCH & BAJAJ, AND in Food Grade are like: GEMINI, RUCHI SOYA, RRO, ALANA etc.

SUMMARY
An intellectual & performance driven professional with over 11.5 years of experience in the field of Quality Assurance ,Production & Quality Control Management. Competent at maintaining quality during manufacturing by ensuring that all work is carried out on the shop floor according to Standard Operating Procedure (SOP). Highly skilled at operation various equipment’s such as Top Load Machine, Melt Flow Index Tester, Vacuum Leakage Tester, Colour Cabinet, etc. Has ability to handle multiple assignments in highly pressured situations and consistently meet tight deadlines or schedules. Possesses strong cost effective organizational skills with excellent employee and client relations.

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