Resume CV : Quality Assurance , Quality COntrol, QA QC

[shivakumar_ash]

OBJECTIVE :
An enthusiastic, versatile, Young individual seeking an opportunity to play a challenging role to the commitment of company excellence.

Academic Qualification :
Diploma in Handloom Technology (Textiles) from Indian Institute of Handloom Technology, Salem Tamilnadu, year 2007 ( with 70% aggregate ).
Now I am Doing 2nd year BBA course under correspondence in Madras University (Chennai, Tamilnadu), ( 1st year second class aggregate ).

Technical Profile :
- Knitted / Woven fabric inspection follows up on 4 point system.
- Woven garments follow up & doing the Online, Mid & Final random inspection as per the global standards/buyer specification (AQL Criteria 1, 2.5 & 4 Level)
- Production Quality monitoring and Executing the orders.
- Good communication skill.
- Basic knowledge of computer, CATD & CCM
- Basic knowledge in Textile Testing
- Basic Knowledge in Textiles wet processing
- Basic knowledge in Weaving (fabric manufacturing).

My Job Profile :
1. Name of the concern : Cuthberts Textile India (p) Ltd, Bangalore.
A Group of Cuthberts international U.K.
Designation : Lab Supervisor
Duration : May 2007 to Dec’ 07.
Nature of Work : Yarn to Garment testing at all International
Standards, Fabric inspection at 4 point system,

2. Name of the concern : Himtsingka Linens
A Devision of Himatsingka Seide Ltd
Designation : Executive Quality Assurence
Duration : Jan’ 08 to Till date
Nature of Work : In line Inspection – Madeups Production
(Trims Audit, Pattern Cutting Audit, Sampling QA,
Online inspection & Final inspection)

Nature of Work and Responsibilities :
1. following fabric inspection on 4 point system
2. Monitoring the Quality of inline production
3. Conducting online inspection
4. Executing the orders
5. The inspection will be conducted on global standards of MIL-STD-105E
& ANSI/ASQ Z1.4, AQL criteria 1, 1.5, 2.5, 4.0, & 4 point inspection for Fabric.

MAJOR BUYERS HANDLED :
Target,
Costco,
Calvin Klein,
DWI,
BBB,
Divatex &
Belk.

PERSONAL DETAILS :
Name : Shivakumar.C
Date of Birth : 23-March-1988
Gender : Male
Nationality : Indian
Marital Status : Single
Languages Known : English, Kannada, Telugu, Tamil, Hindi.
Hobbies : Reading Books, Listening Music, Net Surfing,
Email : shivakumar_ash AT rediffmail.com

Carrier Objective :
To work on Challenging Assignments this will enhance my Technical skill.

Date :
Place :
(Shiva Kumar.C)

[Guest]

Dr. YATHISH.S- GCP Auditor
E-mail : dryathish.qa AT gmail.com

Objective :
Aspiring for a promising and motivating growth oriented career as a Quality Assurance Personnel in Clinical Research field where in, my aptitude and professional skills are best utilised to add value in terms Quality to the Organization.

Areas of Interest :
GCP auditing for Clinical Operations, Data Management, Vendor audits and System audits

Experience :
1. Working since Jul-2010 till date as Quality Assurance Auditor for Asia Pacific (AP) Region in INC Research (Global CRO) located in Gurgaon
- Conducting, Reporting and Closure of both National and International Audits as per the Standard Operating Procedures (SOPs) of the Organization in the Asia Pacific Region (like India, China, Korea, etc)
- Experience in conducting Investigator Site Audits, Vendor Audits, Data Management Audits, Process Audits and TMF Audits
- Has experience in conducting International audits in Asia Pacific region like Investigator Site Audits, Vendor Audits, Process Audits and TMF audits in various countries like China and South Korea, Hong Kong, etc
- Hosting Sponsor Audits

2. Working since May-2008 to Jul-2010 as a Clinical Quality Assurance Personnel in Clinigene International Limited located in Bangalore :
- Conducting Investigator’s site Audits (Therapeutic Areas : Oncology, Diabetic, Osteoporosis, Rheumatoid Arthritis, etc.)
- Implementation of Quality Management system of Clinical Operations and Clinical Data Management
- Conducting System Audits and Gap analysis to implement the QMS in various departments.
- Active Member of SOP Management Team and Implementation of E-enabled SOP management System.
- Training the Clinical Operations team in Regulations and Guidelines including FDA regulations.
- Auditing computerized system validation and ensuring 21 CFR Part 11 Compliance

3. Four years clinical practice as a Dentist :
Clinical Experience of 4 years with the Educational background has added value in my career of Clinical Research in terms of understanding the Medical aspects of the Protocol, Understanding the Source data at site and development of Interpersonal Skills.

Educational Qualifications :
Degree/Course College & University Scores Year of passing:
M.Sc clinical Research (Full Time-2 Years) Institute of Clinical research (India)- Cranfield university-UK 78% 2008
Post graduation diploma in Pharmaceutical management (Full Time 1 Year) Institute of Clinical research (India) 79.8% 2007
Bachelor of Dental Surgery Government dental college- Rajiv Gandhi university of health sciences 65.11% 2003
SAS Base By Certified SAS Programmer Pass 2008

Achievements and Professional activities :
- Trained in 21 CFR Part 11 by International Trainer of Compliance Online Organization
- Implementation of Quality Management System in Various Departments
- Awarded as “Best outgoing student” of MSc clinical research 2006-08 batch of Institute of Clinical research (India), Bangalore
- Certification of excellence awarded for securing Second place in Academics for MSc 2006-08 batch of Institute of Clinical research (India), Bangalore
- Awarded First prize in Scientific Quiz held in October-07 in Institute of Clinical research (India), Bangalore
- Work shop on PharmacoVigilance training by Upsala monitoring center.( 12th and 13th April)
- DIA conference on drug discovery and Clinical Development in India “Opportunities and Challenges” ( October 16th to 18th 2006 )
- International Conference on ‘Clinical Research and Development in India’ ( on 14th & 15th April ,2007)
- Participation in a State Level Elocution about Clinical research in T-John group of colleges.

Skills Summary :
- Understanding of Quality Management System and Auditing Methodology
- Problem Solving ability and Leadership skills, Good inter personal skills, Good team player, Multitask oriented, Eagerness to learn and apply new ideas, self motivated and hard working.
- Basic computer skills and ability to learn new technologies quickly.

Academic Projects during M.Sc in Clinical Research :
- Preparation of protocol and other clinical trials related essential documents for Evaluation of efficacy and safety of Tinospora Cordifolia in Chronic Idiopathic Urticaria (Clinical trials for a Novel therapy in Chronic Idiopathic Urticaria).
- Irrational use of ‘Fixed dose combinations’ in Dentistry- A prescription based study.
- An Overview Of Motivational Techniques Employed In Pharmaceutical Industries And Clinical Research Organization.