1. RESUME
ARAVINTHAKUMAR GNANASEKARAN,
# 1, Patil House, Krishna Nagar, Near Parasmani Building, Dehali, Bhilad Village, Taluka: Umbergaon,
District: Valsad, Gujarat, India. Mobile: +91 - 8140430568, Email: sachinarvind79@gmail.com
QA/RS/001, Rev. 03, 05.05.2016 Page 1 of 4
To seek a responsible and challenging career which provides opportunity to unveil my skills and
continuously develop them while at work.
Summary of Skills
Comprehensive knowledge and Strong background in the area of documentation related with
WHO-GMP, NSF-GMP, ICH, ISO 9001, ISO 13485, ISO 14971, CE Marking, Kosher, Halal, &
Organic - Certifications.
Professional Experience
M/s. K. Patel Phyto Extractions Pvt. Ltd, Bhilad, Gujarat State, India
Manager - Quality Assurance From March 2010 to Till date. (6Y, 3M)
Audits faced
ISO 9001:2008, FDA, NSF-GMP, Kosher, Halal, Organic certifications, Customer audits such as
The Himalaya drug company, Shasun pharmaceuticals limited, Ranbaxy limited, Lupin limited,
Cipla limited, Akums drugs & pharmaceuticals limited, Purdue Pharma, Glaxo smithkline
pharmaceuticals limited, etc.,
Responsibilities
o Overall responsibility of quality management systems & quality assurance department.
o Review and approve of technical documents such as master formula records,
batch manufacturing, packaging records, standard operating procedures, site master file,
quality system manual, quality system procedures, validation master plan, process, cleaning
validation, equipment / Instrument qualification documents (DQ, IQ, OQ & PQ),
product drug master file / common technical document, technical agreements,
stability protocols, annual product quality reviews & trend analysis.
o Responsible for the review and proper investigation of root cause of market complaints,
external audit non-conformance reports & batch failures or nonconformance to specification
of system / product ensuring completeness of corrective and preventive actions.
o Responsible for the initiation, review, assessment and final approval / reject of change
control, deviations, out of specifications.
o Making sure that internal audits / self-inspection & management review meeting were
conducted effectively within scheduled time frame.
o To conduct vendor audit of raw material vendors and third party contract laboratory.
o To handle of customer queries and communication to customers / marketing internal or
external by coordinating with other departments.
o To ensure training on GMP, 21 CFR 111, ICH, ISO, WHO, personnel hygiene, gowning &
de-gowning procedures of immediate subordinates, departmental job specific training and
monitoring of training of all personnel working in the site as per training schedule.

2. RESUME
ARAVINTHAKUMAR GNANASEKARAN,
# 1, Patil House, Krishna Nagar, Near Parasmani Building, Dehali, Bhilad Village, Taluka: Umbergaon,
District: Valsad, Gujarat, India. Mobile: +91 - 8140430568, Email: sachinarvind79@gmail.com
QA/RS/001, Rev. 03, 05.05.2016 Page 2 of 4
M/s. Mediclone Biotech Pvt. Ltd, Chennai, Tamilnadu State, India.
Assistant Quality Assurance Manager & Management Representative (ISO) From May 2006 to Feb 2010.
(3Y, 9M)
Audits faced
ISO 9001:2008, ISO 14001, ISO 14971, CE Marking, FDA, WHO-GMP certifications,
Customer audits.
Responsibilities
o Preparation and maintenance of request documentation of review, issue, archival, and set
quality assurance procedure.
o To perform & review of standard operating procedures, quality system manual,
quality system procedures, site master file, validation master plan, annual product review &
trend analysis.
o To ensure that all changes are monitored through change / deviation controls.
o To review batch production and laboratory control records of critical process parameters &
quality attributes before release for distribution.
o To review the qualification documents of process equipments, utilities.
o To coordinate various validation activities e.g. process, equipment / cleaning validations and
ensure their completion on time as per master validation plan.
o To coordinate vendor qualification through audits, wherever necessary & evaluation of
questionnaire.
o To ensure complaint handling and investigation with appropriate measures taken to prevent
reoccurrence.
o To plan and carryout internal audit / self inspection and compliance of the quality system to
meet the regulatory requirements.
o To ensure that awareness of cGMP, ISO, ICH requirements are evaluated and updated
through periodic training and audits.
M/s. Prathista Industries Limited, Choutuppal, Andhra Pradash State, India.
Sr. Production In-charge From Sep 2005 to Apr 2006 (7M)
Audits faced:
ISO 9001:2008, ISO 14001, ISO 18001, GMP & Organic certifications.
Responsibilities
o Responsible to handle the team to achieve the set targets and maintaining qualitative ,
quantitative as well as GMP & ISO aspects.
o Responsible to prepare the daily, weekly and monthly reports and react accordingly to achieve
the better targets and to fulfill the qualitative, quantitative and GMP requirements.
o Responsible for planning and its implementation / execution.
o Manpower requirement planning and efficient utilization of available Man power.
o Planning and scheduling of the batches and ensure efficient utilization of the equipment.
o Maintaining all records pertaining to production Batch records, Equipment log books / sheets,
yield and area cleaning records, In-process quality records, etc.
o To ensure proper housekeeping as per standards at workplace and ensure proper
environment and utilities in production area which can affect the quality of the product.
o Preparation and submission of shift schedule.
o Responsible for all activities pertaining to production and strictly following the standard
operating procedures relating to all production areas.
o Supervise working associates on production shop floor.
o Knowledge in handling of equipments like fermentors, evaporators, distillation kettle, reactors,
dryers, centrifuges, filter press, etc.

3. RESUME
ARAVINTHAKUMAR GNANASEKARAN,
# 1, Patil House, Krishna Nagar, Near Parasmani Building, Dehali, Bhilad Village, Taluka: Umbergaon,
District: Valsad, Gujarat, India. Mobile: +91 - 8140430568, Email: sachinarvind79@gmail.com
QA/RS/001, Rev. 03, 05.05.2016 Page 3 of 4
M/s. Lactochem Limited, Tiruvallur, Tamilnadu State, India.
Production Supervisor From Aug 1998 to May 2000 (1 Y, 9M)
Audits faced:
ISO 9001:2008, GMP certifications.
Responsibilities
o To monitor production activity in shift
o Maintaining ISO & GMP related records.
o Training to worker & operator.
o Maintaining housekeeping as per GMP, ISO guidelines.
o Effective manpower handling during shift and production planning.
o Consumption and control of solvent and improvement in product quality and safety in plant
operations.
o Effective handling of documentation work.
Education & Credentials
o M.Tech Industrial Biotechnology in May 2005 (7.7 / 10)
Annamalai University, Annamalai nagar, Tamil Nadu, India.
o Lead Auditor for ISO 9001 : 2008 (Quality Management Systems)
International Register of Certified Auditor (IRCA) in June 2009,
(Certificate No. QMSLA-0518)
Quest International Certification & Capable People, U.K.
o B.Tech Chemical Engineering in May 2003 (First Class 62 %)
Pallavan College of Engineering, Kanchipuram, Tamil Nadu, India.
o SAP R/3 PP (Production Planning) in 2006.
Vesoft Technologies, Chennai, Tamil Nadu, India.
o Diploma in Chemical Technology in April 1998 (First Class 66 %)
Pallavan Polytechnic College, Kanchipuram, Tamil Nadu, India.
o Diploma in Fertilizer Technology (First Class 61 %)
Annamalai University, Annamalainagar, Tamil Nadu, India.
Professional Training
Reduction of Energy Consumption and Design of Scrubber in SYNTAN Plant” in
RPG-BTP India Pvt.Limited, Kanchipuram, Tamilnadu, India.
This project has two parts. The first part concepts with design of filter instead of evaporator in
effluent treatment plant. There by the energy consumption such as steam is avoided and also the
power consumption by pump has been reduced. The second part deals with the design of multi
compared scrubber, there by comparing the two single scrubbers, which is at present existing in
the SYNTAN manufacturing unit, in multicomponent scrubber, the cost of scrubber is less & rate
of liquid solvent is less.

4. RESUME
ARAVINTHAKUMAR GNANASEKARAN,
# 1, Patil House, Krishna Nagar, Near Parasmani Building, Dehali, Bhilad Village, Taluka: Umbergaon,
District: Valsad, Gujarat, India. Mobile: +91 - 8140430568, Email: sachinarvind79@gmail.com
QA/RS/001, Rev. 03, 05.05.2016 Page 4 of 4
IT skills
MS Office, word & xl.
SAP R/3 functional competency & SAS knowledge.
SAP PP - Production planning skill set
o Customizing, Configuring and Maintenance of Material Master, Bill of Materials,
Work centers, Routings.
o Planning Strategies: Make To Stock & Make To Order.
o Customizing for types of Material Planning, MRP Types, Lot Size calculation and
Procurement proposals & Plant parameters, Scheduled Margin Key procedures.
My Qualities
o Ability to work in a team environment & Good Computer skills.
o Working knowledge and understanding of regulatory requirements and guidelines.
o Good written and Verbal Communication Skills.
o Excellent interpersonal skills, ability to coach others.
o Well-developed time and project management skills.
o Sincere, Reliable, Loyal, Truthful, Punctual and have communication & Managerial skills.
Contact address
Name ARAVINTHAKUMAR GNANASEKARAN
Father’s Name Mr. E. Gnanasekaran
Date of Birth 18.06.1979
Marital Status Married
Nationality Indian
Dependent My wife, Two childrens
E-mail sachinarvind79@gmail.com
Phone +91 - 8140430568
Expected Position Head / Manager
Total experience 12 Y, 2 M
QA experience 9 Y, 10 M
Current CTC 8,08,440 lakhs per annum
Current location Bhilad, Near Vapi, Gujarat state
Notice Period 2.5 Months
Relocation Interested to relocate
Present Address # 1, Patil House, Near Paras mani Building, Krishna Nagar, Dehali,
Bhilad Village, Taluka: Umergaon, District: Valsad, Gujarat, India.
Permanent Address S/o. Mr. E. Gnanasekaran, Fertilizer Dealer,
No. 205, Main Road, Perungattur, Hasanamapet Post, Cheyyar Taluk,
Tiruvanamalai District - 604 402, Tamilnadu, India.