SACHIN KUMAR RUHELA
SAHARANPUR
Summary
Adept in Quality Management and proficient with MS-Office, I spearheaded quality assurance initiatives at Advanced Microdevices Pvt. Ltd., ensuring compliance with ISO standards. My leadership significantly enhanced process efficiency and fostered a collaborative work environment, drawing on my analytical skills and ability to innovate.
Overview
26
26
years of professional experience
Work History
Advanced Microdevices Pvt. Ltd.
Ambala Cantt
05.2005 - Current
- Company Overview: The company is ISO 9001 and ISO 13485 certified, involved in manufacturing variety of micro porous membranes (Nylon-66, Cellulose Nitrate, Cellulose Acetate, Polyethersulfone, PTFE, PVDF membranes) and membrane based products required in Micro Filtration, Pharma application, Biopharma application, Medical Diagnostic test and Biotechnology
- These products are widely used in Life Science Research labs, pharmaceuticals, Beverages and electronic industries
- The market constitutes all major pharmaceuticals companies, research institutions, labs etc
- Both within the country and abroad
- Involved in implementation of Quality Assurance measures in the company
- Involved in conducting internal audits and training sessions for employees as per the requirements
- Documentation related to Quality Control, Quality Assurance, ISO 9001, ISO 13485, different regulatory guidelines such as ISO, USP, ICH, MHRA, ASTM, cGMP, GLP etc
- Management of important QA activities such as Change Management, Deviation Management, CAPA Management, OOS Handling, Complaint handling, Environment monitoring etc
- To facilitate external audit e.g
- Customer audit, vendor audits, ISO audits etc
- Continuous updation of Quality Management System in accordance with internationally accepted standards such as ISO, ASTM, MHRA, ICH etc
- Documentation related to Quality Control, Quality Assurance, ISO 9001 and ISO 13485
- Management and handling of Change, Deviation, OOS, CAPA etc
- Handling/closure of customer complaint received from market through Investigation, preparation of investigation report, risk assessment, implementation of CAPA
- Involved in conducting risk assessment for different requirements such as Change, Deviation etc
- To control and issue of documents, records, external certificates, reference documents etc
- To establish, implement and maintain quality plans for running products as well as for products under development
- To develop new test methods (physical, chemical, analytical and microbial) for ensuring better quality of the products at incoming, in-process and finished stages
- Involved in the product development and new projects
- Involved in different studies for different customers (for validation of filter product with specific drug)
- Defining validation, calibration and verification methods for different equipment/instruments, products and utilities
- Involved in creating different documents related to product specification and use e.g
- Datasheets, specification sheets, validation guides, product inserts, product catalog, change notification etc
- Involved in implementation of regulatory requirements for GLP in the company
- Involved in finalization of certificate of quality for different products
- Involved in conducting training sessions for employees as per the requirements
- Involved in validation/qualification of HVAC system and classified areas of ISO-5, ISO-6, ISO-7 and ISO-8
- Involved in conducting internal audits of the different departments of the company as per ISO norms
- Involved in in-house development of different computer software (Technical aspect) as per the requirement of different processes in the company with the help of inhouse team of IT professionals
- Involved in method validation for different test methods used in the company (defining method validation protocols, reports etc.)
- Involved in documentation of different product related studies/validations such as shelf life study, product validation, transit validation, process validation etc
- To facilitate external audit e.g
- Customer audits, Regulatory audits etc
- To ensure vendor/service provider compliance through vendor audits
- Organize health checkup of employees in the company
- The company is ISO 9001 and ISO 13485 certified, involved in manufacturing variety of micro porous membranes (Nylon-66, Cellulose Nitrate, Cellulose Acetate, Polyethersulfone, PTFE, PVDF membranes) and membrane based products required in Micro Filtration, Pharma application, Biopharma application, Medical Diagnostic test and Biotechnology
- These products are widely used in Life Science Research labs, pharmaceuticals, Beverages and electronic industries
- The market constitutes all major pharmaceuticals companies, research institutions, labs etc
- Both within the country and abroad
- Provided support and guidance to colleagues to maintain a collaborative work environment.
Assistant - Quality Control
Indo Nissin Foods Ltd.
Rewari
04.1999 - 05.2005
- Company Overview: The company is a wholly owned subsidiary of Japanese food giant 'NISSIN' who introduces the concept of instant noodles to the world
- Company is manufacturing different types of instant noodles with manufacturing facilities in India and abroad
- Testing of incoming, intermediate and finished products (physically and chemically)
- To control process and process parameters to obtain better quality of products
- Involved in production and R & D activities
- Documentation related to quality control
- Dealing with suppliers regarding quality of the material
- The company is a wholly owned subsidiary of Japanese food giant 'NISSIN' who introduces the concept of instant noodles to the world
- Company is manufacturing different types of instant noodles with manufacturing facilities in India and abroad
Education
M. Sc. - Chemistry, Organic chemistry
C. C. S. University
MeerutB. Sc. - Chemistry, Physics & Math
C. C. S. University
MeerutSkills
- MS-Office
- King soft Office
- Internet interface
- Quality Management
Languages
- Hindi
- English
Disclaimer
I hereby declare that the statements made above are true, complete and correct to the best of my knowledge and beliefs., MM/DD/YY, Saharanpur
Grosssalarydrawn
₹ 8,50,000 p.a.
Personal Information
- Expected Salary: Negotiable
- Father's Name: Late Sh. Raj Kumar Ruhela
- Date of Birth: 10/28/75
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
Timeline
Advanced Microdevices Pvt. Ltd.
05.2005 - Current
Assistant - Quality Control
Indo Nissin Foods Ltd.
04.1999 - 05.2005
M. Sc. - Chemistry, Organic chemistry
C. C. S. University
B. Sc. - Chemistry, Physics & Math
C. C. S. University
Similar Profiles
Shubham SharmaShubham Sharma
Quality Assurance(Management Representative) at CARE PVT. LTD.Quality Assurance(Management Representative) at CARE PVT. LTD.
Flor GinezFlor Ginez
Housekeeper at Rouge Valley MicrodevicesHousekeeper at Rouge Valley Microdevices
Ajay SunilkumarAjay Sunilkumar
Apprentice Machinist at Midwest Advanced Materials Pvt LtdApprentice Machinist at Midwest Advanced Materials Pvt Ltd
Vipin ChauhanVipin Chauhan
Production Engineer at Arise Construction EquipmentProduction Engineer at Arise Construction Equipment
Vaibhav GoelVaibhav Goel
Social Media Manager at Lovely Professional UniversitySocial Media Manager at Lovely Professional University