www.tuvindia.co.in India Pvt Ltd Mumbai Baroda Pune : Auditor

[muthukalee]

tuvindia.co.in

Job Profile - Auditors

Job Title Auditors
Job Code 001/AUD
Department Certification
Reports to Branch Head/Manager
Education 1st Class Graduate/Dip in Mechanical/Automobile/Electrical/Chemical Electrical/Civil engineering
Experience 6 - 12 years
Place of Posting Mumbai / Baroda / Pune / Delhi / Kolkata / Chennai / Bangalore / Hyderabad / Coimbatore / Ludhiana
Competencies
Certified Lead Assessor of ISO 9001 : 2008,
ISO 14001 : 2004, OHSAS 18001 : 2007,TS 16949,
AS 9100,ISO 27001,SA 8000,HACCP.

Knowledge of Applicable regulatory and Statutory compliances
Excellent communication and presentation skills
Good Listening ability
Excellent Analytical skills
Good Team Player
Position Objective To conduct audits
Job profile
Auditing as per schedule
Auditing as per regulations and procedures (as applicable)
Reporting
Flair for Marketing would be an added advantage

About us :
TÜV India Private Limited was established in 1989 as part of the RWTÜV group's Indian operations. The merger of RWTÜV and TÜV Nord resulted in the formation of the new TÜV NORD group with a workforce of 7,000 employees worldwide.

Contact Details
Manager - HR
022 - 66477000
801, Raheja Plaza- 1
L.B.S Marg,
Ghatkopar - (West)
Mumbai - 400 086
Email : career@tuv-nord.com
http://tuvindia.co.in

[Guest-IJT]

Name : Ashok Gawate
Email : ashok.gawate AT rediffmail.com
Designation / Skillset : AGM - Regulatory Affairs API
Application for post of General Manager - RA (API)

Resume :
RESUME
NAME
Gawate Ashok Devidas
___________________________________________________________________
OBJECTIVE
To obtain an opening in Regulatory Affairs dept. in well established pharmaceutical /
bulk drug organization.

__________________________________________________________________

EDUCATIONAL QUALIFICATION
M.Sc. Organic Chemistry 1993 from Shivaji University Kolhapur Marks 66%
Additional Qualification
Approved as Lead Auditor for ISO 9001 :2000 QMS from TQMI.
_________________________________________________________________
EXPERIENCE
Presently with M/S CADILA PHARMACEUTICALS LTD
Ahmadabad from 30/09/2008 onwards as a
Assist. General Manager Regulatory Affairs (API).
M/S Sun Pharmaceutical Industries Ltd. (API Mfg Plant)
from 18/09/2000 to 27.09.2008 as a
Assist Manager Regulatory Affairs
Exon Laboratories Ltd. Mahad (sister concern of IPCA)
As QA/Q.C. Officer, 6/3/99 to 16/09/2000

Kopran Ltd, Mahad
As QA/Q.C.Chemist, 1/09/95 to 15/02/99

Vinati Org. Ltd. Mahad
Chemist, 01/07/93 to 31/08/95
Involved in following Regulatory activities at Cadila Pharmaceuticals Ltd– Ahmadabad
1. Review and submission of Drug master files to various regulatory agencies such as EDQM, MHRA, USFDA, TGA, Japan, Korea and in other market.
2. Responses to deficiencies received from regulatory authorities.
3. Submission of annual updates and amendment to regulatory authorities.
4. eCTD submission of DMF in EU and in US authorities through electronic gateway.
5. Preparation of action plan in co-ordination with QA and R&D for submission of responses in time.
6. Communication to authorities and customers related to regulatory queries
7. Review and approval of Process development reports.
8. Preparation of registration documents for various countries.
9. Co-ordination for New drug approval from DCGI.
10. REACH registration in Europe
11. GMP audits of API manufacturing facilities
12. Training on changes to regulatory requirements.
13. Approval of change controls.
In Cadila Pharmaceuticals Ltd, I am reporting to Vice President Quality.
Involved in Regulatory activities at Sun Pharmaceutical Ind Ltd
1. Preparation, review and submission of Drug master files for various regulatory agencies such as EDQM, MHRA, USFDA including response to deficiencies.
2. Communication to authorities and customers related to regulatory queries
3. Review of documents related to DMF preparation.
4. Preparation of registration documents for various countries.
5. Indian Food & drug administration license activities for manufacturing & other approvals New drug approval from DCGI
6. Integrated management system implementation as a Management representative. It covers ISO 9001 :2000, ISO 14001:2004 & OHSAS 18001:1999
7. Training of GMP, ISO to employees.
8. Preparation of registration documents for various countries.
9. Analytical & process validation data verification and approval.
10. Review of SOP, Change control and other QA documents
11. Internal audit of the API facility
Involved in following QA / Regulatory activities at Exon Laboratories Ltd and Kopran Ltd, Mahad and Vinati Organics Ltd
1. Preparation and review of documents related to regulatory submissions
2. Documentation as per ISO 9001 :2000 Quality management system.
3. Review to Batch manufacturing record, specifications, MoA, SOPs and other QA related documents.
4. Audits of manufacturing facilities.
5. Review of analytical records.
6. Sampling and Analysis of Finished drug substances, intermediates and raw materials.
7. I handled instruments like HPLC, Gas Chromatography.
______________________________________________________________________
Present Salary
14 Lac / - PA

-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4362340
Date & Time : 12th Jul 2011 12:43 PM (UTC)
IP Address : 123.201.16.246
Browser Info : Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.1; SV1; GTB7.1; .NET CLR 2.0.50727; .NET CLR 3.0.4506.2152; .NET CLR 3.5.30729)
Predicted Country : India

[Guest]

Adhyaru Darshan Vipinchandra.
Email : dipdarshan48 AT hotmail.com
STRENGTHS

Highly motivated and results driven mechanical engineer with over 25 years of continuous experience in plastic industries of India and abroad. Aggressive in identifying and resolving inefficient procedures and processes. Committed at completing demanding projects within crucial timelines. Thorough; detail and process oriented; strong follow-through skills. Known for analyzing a situation, and quickly implementing innovative resolutions. Highly articulate, demonstrating excellent interpersonal skills across all levels including the effective exchange of complex technical/manufacturing/industrial data. Flexibility with respect to long and variable hours of work. Core competencies include :
- Quality Assurance, Production Control - Extrusion. Compounding,Weaving,Lamination
- UL testing (UL94, UL746A) - Audit, Safety,Regulatory Compliance
- ISO 9001 :2008, ISO 14001:2004, OHSAS:18001,
ISO 22000 :2005 - Concurrent Project Management
- Team Building, Training & Leadership - Process & Performance Optimization

SKILLS AND CAREER ACHIEVEMENTS

- Innovation – research and application of new technologies and methods to improve products and services.
- Technical expertise – in-depth knowledge of diverse aspects in Operations and Quality Control in Extrusion, compounding, weaving, Lamination..
- Management – coordinate with professionals to deliver integrated, high quality products and services.
- Planning – institute long-range forecasting for growth and improvement of quality.
- Leadership- Controlling the qualified work force of more than 200 people.
- Client relations – maintain focus on client needs and expectations and ensure satisfaction and improve Quality of products.
- Expertise in implementation & Maintain the Quality Systems like ISO 9001, ISO I4000, ISO 22000, ISO 18001-OHSAS
- Establish and framework of MIS and Quality Circles to enhance organizational effectiveness
- Successful in effectively handling projects (like UL lab set up, System Certification, Modifications and Developments).
- Founder member in commissioning and Setup of new plants.
- Computer Skills – M.S office - Word, Excel, Power point, internet, email.
PROFESSIONAL EXPERIENCE
Deputy General Manager-Works Oct 2011 till date
EBULLIENT PACKAGING LTD. Silvassa
Over all in charge and functional head of entire operation, quality and having administrative control of the unit. Managing the work force of all departments for monitoring the Quality and Output for production of Polypropylene Jumbo Bags (FIBCs) and other flexible products.

Manager-Quality Assurance Oct 2008 to Sept2011
SHANKAR PACKAGINGS Ltd. Baroda
Over all in charge and functional head of QA department. Managing a team of quality engineers for monitoring the Quality and Output for production of Polypropylene Jumbo Bags (FIBCs) and take corrective action for improvements and also achieving operational goals, through departmental Target review analysis , internal audits , development activities. “Management Representative” for ISO 9001 :2008 (Q M S) and “Food SafetyTeam Leader” for ISO 22000:2005 (FSMS).

Assistant Manager-Business Management Systems Jan 2008 to Oct 2008
GREEN CIRCLE CONSULTANTS INDIA Pvt .Ltd. Baroda
Management Representative for ISO 9001 :2000. Provided Consultancy services to Clients, including Documentation, Awareness Training, Internal Audits up to final certification for ISO 9001:2000, ISO 14001:2004, OHSAS:18001 and other systems and also client support for all ongoing projects.

Senior Executive (System & Devp.) Sept 2004 to Aug 2007
SHANKAR PACKAGINGS Ltd. Baroda
Management Representative for ISO 9001 :2000 (Q M S) and HACCP (Food Safety). In charge of EHS activities. Planning, Internal Audit, Management Review Meetings, Daily NC product control, Corrective actions, Improvements, External Audits.
Day QA/UL Tech. 1995 to 2004
GE PLASTICS SINGAPORE Ltd. Singapore In charge of all Physical property and analytical tests. Educate, manage, Motivate the Shift QA Technical team. Operation, Quality, analytical and UL Checks. Handling of injection molding, Lab testing & equipment Calibration. Complaints Investigations and external test support.

Manufacturing Team Member 1994 to 1995
GE PLASTICS INDIA Ltd. Baroda
Performed duties in Operation, Maintenance , QA and Logistic departments.
Duties related to the field of development of new colors and Trouble shooting Operations.

Works Engineer 1986 to 1994
SHANKAR PACKAGINGS Ltd. Baroda
In charge of Complete Production department, i.e.Tape plant operation, Circular Weaving Department and Finishing Section, QC lab. Effective overall management and hands-on experience in manufacturing of HDPE / PP Woven sacks. Motivation and Coaching of employees.

Plant Operator 1984 to 1986
AMARTARA Ltd. Baroda
Operation and Maintenance of PVC, Paper, Cellophane, nylon adhesive coating plant. Operation and maintenance of PVC stretching plant Including QC checks.

EDUCATION
1981 - 1984
MS UNIVERSITY Baroda
Diploma in Mechanical Engineering

1980
GSEB Baroda
Secondary School Certificate
PROFESSIONAL QUALIFICATION

- PG Diploma in HSE (Health Safety & Environment) , National Institute of Fire & Safety, Surat,2011 (Pursuing)
- Lead Auditor for ISO 9001 :2000 , BVQI, Baroda, 2007
- Internal Auditor For EMS 14001 :2004, Green Circle, Baroda, 2008
- Internal Auditor For OHSAS 18001 :2007, Green Circle, Baroda, 2008
- Certified for property testing of UL946 A & UL94 (Polymeric Testing), By Underwriter Laboratory of America, RTP, USA.
- M.S. office and Basic of Computers - LCC Computers, Baroda
TRAININGS
- On The Job Training Instructor - Institute of Technical Education, Singapore
- Six Sigma Quality Training - GE Plastics, Singapore
- Focused EHS Awareness Training - GE Plastics, Singapore
- Training Course for safety Committee Member - Constructive ESHQ of Singapore
- Training on accident/Incident Investigation - Constructive ESHQ of Singapore
- Certificate of EHS committee member - GEP, Singapore
- TPM (Total Preventive Maintenance) Action Course - PSB, Singapore
- Group effectiveness Module Training -Productivity Board of Singapore
- Plastics material and Extrusion compounding course - Singapore Polytechnic
- PC hardware & software Technical training - Cron Computer , Singapore
- Forklift Driving and Operation Course - Singapore ports authorities’ institute.
HONORS

- Appreciation Certificate for Extra Hours of Working - GE Plastics,Singapore
- EHS Champion for QA , recognition for my excellent work during Global Star-Safety Audit and Implementati

[Guest]

RESUME
ELANGO.A.MUDALIAR
E-mail : elangomudaliar17 AT rediffmail.com

CAREER OBJECTIVE
Seeking Quality Auditor in Manager post in Engineering Manufacturing and Computer software development industries as per my education, knowledge, experience and attitude.
Experience in internal auditing about 7 years and Certified Internal Auditor trained by TUV Asia Ltd., PPAP. Poka yoke, Kaizen, Six Sigma and other type of training taken at Mahindra& Mahindra for the Last seven years around 10 times. And attended Competition in all above categories by M&M.
WORK EXPERIENCE
Core Competencies
Software : MS office
Current Employment
1.) Company : Delux Engineering, Mulund, Mumbai.

Company Profile : Automobile, Mahindra vehicle Door Hinges and Press components.

Designation : Quality Manager, Internal Quality auditor certified, and PPAP,5S,Kaizen.
Responsibilities in general :
- Setting and controlling Quality Target.
- Follow up Internal Kaizen, Pokeyoke development project.
- PPAP, Internal audit documentation.
Duration : Jan’ 2005 to till date.
Previous Employment
2.) Company : Raunak Enterprises, Mulund, Mumbai.
Company Profile : Manufacturing Non ferrous press components for Automotive and Electricals Manufacturers.
Designation : Manager looking Marketing, Purchase, Design, Production and etc.
Responsibilities in general :
- Identify the customer who required components.(Market)
- Tools and Designing of sheet metal and manufacturing tools inhouse.
- Production and supply in time and get the order for next month.
- Customer support and manpower management and appoint the operators and supervisors.
Duration : May-1997 to Jan’ 2005
3.) Company : Well Product Industries Ltd. Marol, Mumbai.
Company Profile : Manufacturers of Auto electrical components for MICO and Electrical
Contacts for Siemens and L&T.NGEF and others.sheet metal components in Non ferrous and silver contacts.

Designation : Project cum, Production Manager.
Responsibilities in general :

- Project development.
- Machine supplier identify and get quotation for project.
- Minimum 3 Vendor identify and contact with them.
- Project report preparation.
- Submit to Bankers and get loan from them.
- Product development inhouse, Tool design and development.
- Report maintain.

Duration : May 1992 to May 1997
4.) Company : Modison Metals Ltd.,Nariman point, Mumbai.
Company Profile : Manufacturers of Electrical contacts in Silver.Copper, Tungsten,Nickel.
And supplied to Siemens,NGEF, and other local manufactures.

Designation : Vendor development and Production Engineer.
Responsibilities in general : Development of Product in silver strip, bimetal rivets,Sliver nikel profile strip rolling, wire drawing, Draw bench, Silver melting and refinery and Powder compacting products like silver-Tungsten. Copper Tungsten, Silver Graphite compacting, sintering, brazing, slitting and serration rolling.

- Over all production and product development

Duration : Dec-1987 – May-90
PROFESSIONAL QUALIFICATION
1.) Course : Diploma in Mechanical Engineering (DME).
Institute : Nachimuthu polytechnic, Pollachi, Tamil Nadu Technical
Board
Percentage : 78%
Duration : 3 Years.
ACADEMIC QUALIFICATION
Degree Year School/College/University
DME 1984 Nachimuthu PolyTechnic, Pollachi, Coimbator dist.
TamilNadu Technical Board of Education
Post Diploma 1991 Annamalai University, Karaikal
10th Board 1981 Government Higher Secondary School, Mulanur,
Dharapuram T.K.
EXTRA CURRICULAR ACTIVITIES
Playing Cricket, internet chating, and supplier identifying international level according to company
Company requirement and development project