G. YUVARAJ M.Pharmacy.,Ph.D.

, WHO GMP*
78/45 nandhan st,Villivakam,chennai
cell phone: +91 9952968059

ACHIEVEMENTS
I have got first rank in the written test conducted Production
Betalactams/Non Betalactams and QC Pharmaceutical Testing Analysis
Programs during Conducted and PowerPoint Presentation(training
program in CSI,Chennai).
I had been appreciated for my outstanding performance Clinical
program during my training program in company
Recorded highest Research activities as well as FUNDING
PROJECTS (5 core ) in Pharmaceutical chemistry/Drug discoveryLiquid Orals Vials/ampoules works TIE UP with CSI company.(PG/PhD
student Guide)
STRENGTH
Self evolving excellent problems solving interpersonal & good communication
skills.
Training program Presentation to ISO standards/ANVISA/CE Markings-except
Computer skills fast data base and Documentation-production.
Team Head-cooperation
Personal particulars:
Date of birth

23rd april 1980.

Nationality

Indian

Gender

male

Address

ODCL Govt of India

Martial status

Married.

APPLY OF POST : Team head oral Powder/Liquids

(b) Desirable:
(i) Research papers/patents in any of the fields specified in essential
qualifications above. The claim must be supported by submitting
relevant paper(s)/documents published/ drug analysis experience. Yes(47
International Research articles-Mostly 1 st authorship)*
(ii) Experience in interpretation of analytical specifications of drugs &
Pharmaceuticals-Yes attached
(iii) Experience of working on MS Office Word, Excel, Power point
etc. Yes
Academic: Ph.D Thesis work Pharmaceutics Formulation.
CPGA-9.7 in Out of ten-Company sponser-CSI funding 3 core Projects
DrMGR UniversityChennai-95.Dr.MGR Medical university-JSS
college(Now JSS university), Ooty.IndiaPh.D- Pharmaceutical (Pharmaceutics and Formulation various dosage
forms )*
Dr.MGR University, Chennai, India-B. Pharm (2 subject
Out standing medal)
Small Industries Service Institute, Chennai, India
Academic TIE UP projects-FUNDING PROJECT-6-8 crore US Projects
CRC group/56 Lakh Singapore CSI company
M.Pharm/ PG projects-Regulatory affairs
Need of regulatory affairs in Clinical research
To discover a
New drug
Treatment
Diagnosis
Device which is Safe & Effective for human
beings
Regulatory affairs in Pharmaceutical industry

 Aim - Protection of human health

Ensures - Safety, efficacy, quality of drugs, Accurate drug information
Regulates Production, import, export, storage, distribution, sale, supply
of drugs
Applied National, international level
Effective in few developed countries

RESPONSIBILITIES HANDLED

Maintaining daily activity report

Line inspection
Incoming inspection
Outgoing inspection
Row Materials inspection
Manage contractors file
Manage incoming And outgoing files
Checking Welding Missing Or not
Checking gap between two body runner
Checking Welding Thickness not less then 4mm CSI PVT Ltd.
Performing inprocess quality assurance checks for tablets, capsules and

liquid orals.
Issuing of line clearance at every step of batch manufacturing.
Maintaining and updating the Batch Manufacturing Records.
Documentation of log books, caliberation records, temperature and
humidity records etc.
CRC group Hyderabad: Assisted in production of various
products.Managing & facilitating the sampling, analysis and reporting of
microbiological quality of raw materials, Packaging material swabs,
Environment samples (water/air/hand swabs/equipments etc),
Inprocess /Line samples, finished products.
- Documentation, Implementation & certification ISO 22000:2005 Drug
Safety Management System/HACCP, ISO 9001:2008 Quality
Management Systems and ensuring the Quality norms .
- Overall supervision of Production Zone& implementation of Rapid test

methods for product Uint quality assurance and ensure all results are
correct and accurate.
- Geared the activities for support & development of Suppliers and
setting mutual objectives. Aligning QA function vision with the
Company goals, leading the team for achieving the objectives and
building alliance to support other functions and overall business
- Initiated turnaround efforts for ensuring that the Drug safety standards
are followed in accordance with local and international requirements
- Conduced hazard analysis based both on Drug safety as well as general
safety in order to provide safe working environment
- Developed all specifications for purchased ingredients and Drug
packaging materials, as well as procedures for incoming inspection to
ensure compliance
- Successfully conducted regular audits and Drug safety awareness
trainings for vendors
- Imparted training to employees on the various issues related to Drug
safety, maintenance and implementation of HACCP standards
- Conceptualized and implemented measures for enhancing operational
efficiency & optimizing resource optimization
- Constantly monitored day-to-day operations at micro level, maintained
daily checklists and executed the tasks assigned in accordance with
organizational standards-- Conduct foreign body audits of ISO 22000,
ISO 9001, Halal, SEDEX and customers
- - Managing & facilitating the sampling, analysis and reporting of
Production zone and Packaging material swabs, Environment samples
(water/air/hand swabs/equipments etc), Inprocess /Line samples, finished
products.
- Implementation of Rapid microbiological test methods for product Uint
quality assurance and ensure all results are correct and accurate.
- Monitoring, sanitation and validation of the process equipments as well
as laboratory equipments, Validations activities in the lab.
- Generate pathogen-monitoring results daily. Compile monthly summary

for review by management. Corrective Action Reports for all Drug safety
related deviations. Pest Control Monitoring Report.
Current :Head/ODCL-Bhubaneswar WHO GMP Documentation *GOVT
Of India
-I am a pharma professional with 13 + years experience in pharma formulations
field in functions like production, QA, QC, engineering, R&D etc.
-I am well versed in sterile as well as non -sterile dosage forms.
-I can handle projects from concept stage to commercial production.
- I am well versed in cGMP practices and also ISO 9000 QMS.Iam looking for a
job change for better prospects./ I had successfully faced international audits in
my previous tenures.- Developing production plans & schedules, arranging
resources to ensure achievement of targets as per budgeted parameters.
Maintaining production volumes through constant interaction with sales teams.Implementing new process concepts for production optimization, yield
improvement and formulating guidelines for the sequencing of manufacturing
activities on the assembly line & shop floor processes.
- Devising cost saving measures & modifications to achieve substantial
reduction in terms of man days, production cost, raw material & energy
consumption.Devising process changes for qualitative improvements in
productivity & reducing the rate of rejection.Identifying capacity limitations &
bottlenecks and process problems, plant upsets, reasons for production shortfall
for taking corrective action. Executing cost saving and energy saving
techniques/ measures and modification to achieve substantial reduction in
operational work within the budget. Undertaking process validation, cleaning
validation for a control on process parameters to get optimum production with
the safety of man and equipment.
Process Improvements
Undertaking regular inspections to prevent accidents and adhere to safety
norms.
Developing and implementing plans & schedules for Maintenance
Operations and Annual Turn Around with focus on optimum utilization of
manpower and material.
Maintenance Operations
Planning and implementing proactive / predictive / preventive / shutdown
maintenance schedules for machinery so as to increase machine up time /
equipment reliability.

Additional Qualification:FDA approved for Chemical and Instrumental Analysis

Regulatory Authority in Japan
Pharmaceuticals & medical devices evaluation centre
Established in 1997 to strengthen governments evaluation capacity for
securing safety & preventing harmful side effects of pharmaceuticals
Evaluates quality, safety, efficacy of each prescription drugs & medical
devices as well as proprietary drugs, cosmetics that are purchased directly
by public
Process for the approval of newly developed drug
Applicant must apply to ministry of health, labour & welfare (MHW)
with the data
MHW leaves the data reliability survey to external institution
after evaluation by different officials with different back ground
The report is submitted to pharmaceutical affairs & food sanction council
(PAFSC), which is a consultative body of minister
Based on this report the ministry finalizes the whether they should
approve the drug or not.
Regulatory Authority in Republic of Latvia Non profit state joint stock
company state agency of medicines ( SAM )
Founded on 9th Oct, 1996
SAM acts in accordance with
Pharmacy law
Law of joint stock companies
Law of non profit organizations
Other regulatories
Regulatory Authority in Canada
Health Products & Food Branch (HPFB)
Integrated approach to the management of risks & benefits related to
health products & food by
Minimizing health risk factors to Canadians while maximizing the
safety
Promoting conditions that enable Canadians to make healthy
choices & providing information so that they can make informed
decisions about their health

 HPFB inspectorate is responsible for management of inspection,

investigation, monitoring activities related to fabrication, packing,
labeling, testing, import, distribution of regulated health products for
human & animal use
GMP (schedule- M)
FACTORY PREMISES
The manufacturing plant should have adequate space for
Receiving raw material
Storing raw material
Manufacturing process area
QC section
Finished goods store
Rejected goods/ drugs store
office
General requirements Location & surroundings avoid contamination from open sewage, drain
etc which produces disagreeable odor, fumes, smoke etc
Buildings premises used for manufacturing, processing, packaging,
labeling will be in conformity with provisions of Factory Act
Water supply pure water must be used.
Disposal of waste waste water & residues are disposed off after suitable
treatment as per guidelines of pollution control authorities to render them
harmless
Containers cleaning adequate arrangements separated from
manufacturing operations for washing, cleaning, drying of containers
Stores adequate space for storage of different types of material, such as
raw material, packaging material & finished products
Raw materials care must be taken to handle different kinds of raw
materials. Each container used for raw material storage shall be properly
identified with label clearly stating the status (approved. Under test,
rejected). Raw materials shall be sampled & tested either by in house or
laboratories by government. Records of receipt, testing, approval,
rejection shall be maintained
Packaging materials containers, closures shall be cleaned & dried
before packing products
Finished goods stores finished goods are stored within an area marked
quarantine. Only approved finished goods after QC tests will be
dispatched. Distribution records shall be maintained.
Working space adequate place to facilitate easy& safe working and to
minimize risk of mix-up, cross contamination etc

 Health, clothing, sanitation & hygiene of workers

Medical services adequate facilities for first aid. Medical examination
of workers periodically
Equipment based on size of operation, nature of product manufactured
suitable equipment shall be made available. SOP for cleaning,
maintaining etc of machine shall be laid down
Batch manufacturing records (BMR) the licensee shall maintain BMR
to provide an account of list of raw materials, quantities obtained,
chemical tests performed etc. it is essential to maintain records for each &
every process
Distribution of records records of sale & distribution of drugs shall be
maintained in order to facilitate prompt & complete recall of batch
Record of market complaints once in 6 months manufacturer shall
submit record of complaints to licensing authority. The register shall also
be available for inspection. Adverse reactions reported on the product
shall also be recoded
The quality control section shall carry out the following functions
The section should be provided with an area of 150 sq. feet
Samples should be maintained for identification of raw drugs & for
reference
Manufacturing record should be maintained for the various processes
carried out during manufacturing
Supervise & monitor adequacy of conditions under which raw materials,
semi finished products & finished products are stored
Keep records of shelf life &storage requirements for drugs
All raw materials will be monitored for fungal, bacterial contamination
with a view to minimize such contamination
The standards for identity, purity & strength as given in respective
pharmacopoeias of Ayurveda, Siddha & Unani systems of medicines
published by government of India shall be complied
Requirement for sterile products
1. Manufacturing area
For manufacture of sterile ayurvedic, siddha, unani drugs separate
enclosed area (dust free, properly ventilated) shall be provided.
HEPA filters are to be used. Manufacturing areas shall be restricted
to minimum number of authorized personnel
2. Precautions against contamination and mix

 Provide a suitable exhaust system

Carry out manufacturing operations in a separate block of
adequately isolated building
Expert technical staff approved by licensing authority shall check
the yield
Room relative humidity, volume filled, leakage & clarity should
be checked & recorded
THE GLOBAL AYURVEDIC PRODUCT MARKET
The global Ayurvedic market is booming. The reported growth rate is 910 % per annum
The herbal drugs in India is presently estimated to be around 2,300 crores
with a 15% growth/annum
Since, the rise of Ayurvedic medicines Kerala is fast becoming a unique
selling proposition (USP) to earn for exchange for the country
An Indian system of Medicine & Homeopathy drug policy is currently
establishing
A medicinal plant board & GMP authority is reportedly being constituted
to implement good manufacturing practices
The government has set up an independent body of experts, called
National Pharmaceutical Pricing Authority, to do the work of price
fixation for drugs.
This body would also monitor the prices of decontrolled drugs &
formulations & oversee the implementation of provisions of Drugs Price
Control Order
Government will keep a close watch on prices of medicines, which are
taken out of price control.
In case, the prices of the medicines rise unreasonably, the government
would take necessary actions
Quality control & rational use of drug
Quality control & rational use of drugs are important aspects of
pharmaceutical industry
Steps have been taken in strengthening the Drug Control Organization by
establishing Sub-Zonal offices at Hyderabad, Ahmedabad, Patna.
The Bio-Laboratory at Madras has been upgraded to level of National
Laboratory
Central Drugs Laboratory Mumbai
Regional Laboratories Guwahati, Chandigarh,
Hyderabad
For certain Drugs like
Large volume Parenterals

Sera & vaccines

Starting /Intial after studies QC department tablets india Pvt
Ltd(UNDER sastri/Senthil sir worked)*2 Years
CSI Pvt ltd-CRc group/PIPER Warangal/hetero drugs-Regulatory
affairs and QA Departmrnt/Country dosage regimen(4 to 5 Countries)*
Responsibilities of Regulatory Affairs Professionals
The regulatory affairs department is the first point of contact between
government authorities & company
Regulatory affairs professionals helps to ensure that the product
development, manufacturing & marketing practices meet or exceed
government requirements
Regulatory affairs program provides graduates with the specialized
knowledge required to help biotechnology, medical device,
pharmaceutical & food companies manage regulatory processes
Students will gain knowledge of international healthcare system,
healthcare legislation, procedures & practices for regulating the
development, manufacture, QA & manufacturing of healthcare products
Regulatory affairs program have an international focus for the following
reasons
Most companies develop products for an international market
Current regulatory processes in most countries are based on international
guidelines
Regulatory affairs professionals must ensure that the product information
submitted to the authorities is as complete as possible & in the correct
form
They are also responsible for subsequent contacts with the regulatory
authorities
Since authorizations are issued for a specified time, & have to be renewed
before expiry, a very important part of regulatory affairs function is
maintenance & updating of authorizations
Regulatory professionals will critically review all the scientific evidence
presented by the company to establish the products quality, safety,
efficacy
Regulatory affairs executive has the responsibility to communicate with
all people within the pharmaceutical company, external communicants,
medics who have an input to all the data that is put together for the
regulatory authorities

 The regulatory affairs professionals will then communicate this

information to the government regulatory authorities worldwide in the for
of Dossiers
Regulatory affairs professionals should be involved at initial synthesis
stages, preclinical stages, clinical stages & all the way through drug
development lifecycle & beyond into product marketing cycle
The whole process of drug discovery & ultimate release into market may
take up to 15yrs & many problems may arise during this period of
scientific development
It is the job of the regulatory affairs professional to help the company
avoid deficiencies in their data, which may create difficulties in the
registration of the product
Regulatory affairs executive has to collect all the documented data, keep
the documents in the correct & specified order, summarize where
necessary, check the validity & make sure there are no conflicts among
the data supplied
Regulatory authorities will generally seek clarification & ask specific
scientific questions from regulatory professionals on the areas of Quality,
Safety, Efficacy & they will require prompt & accurate answer for giving
license to product
After the company got license to manufacture & sell new pharmaceutical
product in the chosen market there is a need to maintain & renew the
license which is the duty of regulatory affairs professional
Skills, which regulatory affairs professional must have are
Key negotiation skills
Project management skills
Information technology skills
Management skills
Interpersonal skills
All these skills are set against a background of ever changing
pharmaceutical regulations world wide
In clinical trials, Regulatory affairs professionals have the following role to
play
Provide strategic leadership for the development & execution of
regulatory plans to support a global drug development plan
Provide the company with regulatory intelligence & expertise in
translating regulatory requirements into practical, workable plans

 Manage the daily activities of personnel responsible for regulatory

submissions, train, mentor & coach regulatory personnel
Ensure timely preparation of organized & scientifically valid submissions
of IND etc
Represent regulatory affairs to other departments & provide guidance on
adherence to regulatory guidelines for effective submissions
Assure adherence & compliance with all applicable FDA/ICH guidelines
& with current GLP,GMP & GCP guidelines
Set objectives for training sessions, standard practices, SOPS &
departmental policies
Responsible for supporting the GCP compliance program by conducting
comprehension audits of clinical investigator sites
Presentation of GCP training to other staff
Provide support to internal & external GCP compliance program
Planning, scheduling, conducting, coordinating investigator sites
according to SOP, applicable regulatory requirements
Assisting in performing internal systems audits, reviewing clinical
documents
As a product goes through the review process, regulatory affairs
professionals are looking at requirements for manufacturing, packaging &
advertising
Manufacturing is related with QA, QC
Packaging, labeling & advertising will also interfere with manufacturing
There are stringent regulations everywhere that govern these spheres
Regulatory affairs personnel work with distribution & make sure the
processes meet regulatory requirements
Once the product is in use, regulatory affairs professional is also involved
in reporting any adverse effects of a drug to FDA
Minimum requirement for an individual to enter into regulatory affairs
profession is to have a scientific background in order to have the
knowledge to ask the scientists the right questions in the light of a vast
quantity of product data, pharmaceutical legislation & guidelines
Having some working knowledge of the industry is always preferable
The usual requirement is a degree in life science, pharmacy or medical
degree with some experience in pharmaceutical /biotech industry
Skills Required

Good Written Skills

Verbal communication skills
Problem solving abilities
Critical/analytical thinking skills
Ability to plan & manage multiple projects
Meeting deadlines

Accommodate changing priorities

Assignments
Proficiency in computer applications
Interpersonal skills to interact with other departments effectively
In the pharmaceutical industry, regulatory affairs professionals should
have expertise in the legal & regulatory environments, as well as in
clinical research protocols
They are the primary interpreters of the laws & regulations for other
members of the company like R & D, manufacturing etc
Regulatory affairs professionals must have a thorough understanding of
the complex set of regulations
Keeping up to date on regulations is essential in regulatory affairs;
changes in regulations can affect the clinical trials process, regulatory
strategy, what kinds of decisions are needed on trials etc
According to some critics the field of regulatory affairs has become
increasingly more science & issue based
As the speed of pharmaceutical & biologics development has increased
science has become more complex
A regulatory professional now spend more time on substantive scientific
& medical issues & planning for experiments & clinical studies to
achieve approval
A regulatory affairs professional has to be able to provide expert opinions
on technical & legal matters associated with registration of products
Regulatory professionals must always exercise considerable integrity &
judgment in the practice of their role
Regulatory affairs professional must have capacity to draw upon the
information provided by specialists (pharmacologists, toxicologists,
chemists, pharmacists, doctors etc) & must be able to synthesize the
knowledge & use it to impart information & make aware of staff about
current regulatory guidelines
As regulatory processes increase in complexity & scope, globalization
occurs within this field, there will be continuing industry demand for
people with a strong foundation in regulatory affairs
Communication & organizational skills are also extremely important in
dealing with government agencies
Advantages of certification
Regulatory affairs certification enhances employment prospects
Many companies, both large & small are now beginning to indicate
that Regulatory Affairs certificate is a desirable qualification
Certified professionals will earn 5-15% more salary than others.

E-LITERACY

 Has Good Knowledge In MS WORD, MS EXCEL, MS

POWERPOINT, SYSTEM BOOTING Etc.
SYBYL 6.7 VERSION (TRIPOS- USA)J.S.S PHARMA
COMPUTER AIED MOLECULAR DESIGN(CAMD)
KNOWLEDGE IN HPLC & LCMS/MS:
Trouble Shooting HPLC & LCMS/MS
Leak Problem
Pressure Problem
Problems with max
Problems with system configuration
Problems with software installation
Problems with mandling and dismandling
Problems with Chromatogram
Method development and validation
Calibration and Validation of HPLC & LCMS/MS
PROFESSIONAL MEMBERSHIP:
.Registered Pharmacist AND IPA (IN The Pharmacy Society),
Chennai.
Qualified in GATE examination.
PUBLICATIONS
National-7/International-67/Seminatr-12(Local/International)
Presentation-seminar
1 yuvaraj, Mathur M, Sonie KK and Ramawat KG, Bioactive polyphenolics and
bulbils formation in Curculigo orchioides shake flask cultures. Poster
presentation in Jaipur,2005.
2 Rathore KS and yuvaraj, Development of Successful Controlled Release
Dosage Forms for Opthalmic Drug Delivery System, AICTE Sponsored
National Level Saminar on Recent Trends in Innovative Drug Discovery and
Research, 34-35, Oct.27-29, 2006.
3 Rathore RPS and yuvaraj, Influence of the Concentration of Gelling Agents on
the Rheological Properties of Gels, AICTE Sponsored National Level Saminar
on Recent Trends in Innovative Drug Discovery and Research, 36, Oct.27-29,
2006.

4 Rathore RPS, Nema RK, Gupta GD and yuvaraj, Effect of PVP on Transdermal
Delivery of Terbutaline Sulphate, AICTE Sponsored National Level Saminar on
Recent Trends in Innovative Drug Discovery and Research 37, Oct.27-29,
2006.CREDIT/Small age achievements:
BOOKs-2 books CBN publication HPLC/HPTLC Pharma
analysis/Production and regulatory affairs Importance