www.progenitorint.com Progenitor Clinical Research Ahmedabad : ICH-GCP Clinical Research Analysis

[Admin]

Progenitor Clinical Research Ahmedabad : ICH-GCP Clinical Research Analysis
Website : http://www.progenitorint.com

CRAs:
2 years minimum experience as a CRA for a CRO or pharmaceutical company required. In-depth knowledge of ICH-GCP requirements and advanced English skills required.

Global Project Managers:
4 years minimum experience leading projects with global experience necessary. In-depth knowledge of ICH-GCP requirements and advanced English required. Advanced degree is preferred.


Please contact us by e-mail at info@progenitorint.com

Indian Head Quarter
Progenitor Clinical Research
B/502 SAFAL PEGASUS 5th Floor
Near Prhaladnagar Garden Anandnagar Cross Roads
100 feet Road-Satellite
Ahmedabad - 380015
India
Phone +91 79 400 66046
Fax: +91 79 400 66047

[Guest Poster]

Dear Sir / Madam

Re: Application for Clinical Research Associates

I am writing to express my interest in securing a Clinical Research Associates position with your firm, in response to your job posting in internet. I am currently employed as Quality Assurance Officer at HLL LIFECARE Limited, an emerging a Navratna organization in pharmaceutical and healthcare sector.
Now I found your esteem concern for proliferate my knowledge and idea for betterment of me and same time dynamically, I may help to enrich your organization for progress with optimization.
In that regard, I would appreciate the opportunity to meet with you to discuss my qualification and the possibility of joining your organization. Please find my enclosed resume for your review. I look forward to be hearing from you.

Yours very truly
Rajeev Kumar Singh


RAJEEV KUMAR SINGH
C/O Mr. YADVENDRA SINGH
HOUSE NO: 1152/29
LAXMAN VIHAR PHASE I
NEAR BERI WALA BAGH
GURGAON 122001
HARYANA Mobile No: +919971321391
Email: captain_raj1800 AT yahoo.co.in
: singhrajeev1800 AT gmail.com
Objective :
To pursue a challenging job and excel at it, to serve the organization with my resourceful and innovative qualities and hard work, and to reach a good position in my respective field of service.

Personal Skills:
- Able to work under optimal supervision.
- Excellent organization, planning and problem solving abilities.
- Excellent negotiation and analytical skills.
- Established interpersonal and communication skills.
- Proficiency in computer i.e. Microsoft office and adapt in internet.
- Able to work effectively and efficiently in a matrix environment.
Academic Performance:

Name of Exams
Institutions Results
P.G Diploma in Clinical Research &Pharmacovigilance Cliniminds , New Delhi Pursuing
Bachelor of pharmacy A. A. I-D.U ,Allahabad Passed-Ist Division(78% 2007)
Diploma in Bioinformatics B.I.I , NOIDA
Passed-Ist Division( 68% 2007)
12th Military School Dholpur Passed-Ist Division( 65%;2001)
10th
Military School Dholpur Passed-Ist Division(78% ;1999)


Summary of Qualification:
- Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.
- Detailed knowledge of Documentation work i.e. related to Log Books, BMR and Quality Manual System.
- Comprehensive knowledge of Covance S.O.P’s for operating procedure, calibration, validation, stability
Testing and site monitoring.
- Detailed knowledge of GCP and ICH guidelines and applicable local and international regulatory guidelines.
- Deep knowledge of monitoring procedures related to clinical trial
- Proficient in analytical knowledge
- To manufacture In-Vitro Immunodiagnostic products and relevant buffer formulation according to GMP/GLP
and ISO 13485:2003 requirements.
- To perform and Clinical Trial of Medical devices of Pregnancy Test Kits, Malaria Kits, Dengue Kits Devices.
- To perform in-process testing, performance verification, validation and QC release of components.
- Creates and maintains appropriate documentation regarding site management monitoring visit finding and action plans by submitting regular visit reports and other required study documentation.
- Ensuring documentation, report and record management as per quality assurance and ISO 9001:2008 guidelines.
- Evaluates the quality and integrity of study site practices related to the proper conduct of protocol and adherence
To applicable regulations.
Project:
- Worked as a team leader for final year project “Quality Control and Standardization Methods of Some Herbal Drugs Formulation.” Performed liquid evaluation, solid evaluation and powder evaluation of various products of ZANDU, DABUR and BAIDYANATH .
Industrial Training:

Industrial Training Arbro Pharmaceuticals Limited New Delhi
Gained knowledge in Production-Tablet, Capsules, Syrup, Quality Control and Assurance and Packaging.
Employment :
- June 2007 to September 2007:
Working as Quality Control Trainee in TWILIGHT LITAKA PHARMA LTD. at BADDI.

- October2007 to till date:
Working as Quality Assurance Officer in HLL LIFECARE LIMITED ( A Govt.of India
Enterprise) at Manesar, GURGAON.
Seminars And Training :
- Seminar about Bioinformatics and industrial technology at IIIT Allahabad
- Attended Pharma Vision 2005 at Greater Noida.
- Training of IS0 9001:2000, ISO 13485-2003; ISO 9001:2008 at HLL LIFECARE Limited Noida.
- Training of Quality management system by QCI at New Delhi.
- Training of Risk management of medical devices at HLL LIFECARE Limited at Manesar, Haryana.
Area of interest:
- Pre-Clinical studies
- Clinical Research
- Pharmacovigilance
Membership :
- Active member of Indian Pharmaceutical Association
Strength :
- Good interpersonal communication and team work
- Strong work ethics
- Highly motivated and result oriented
Hobbies :
- Adventure and traveling, watching cricket matches and interacting with people.
Personal :
Father’s Name Mr. Krishna Kumar Singh
Date of Birth 02/07 /1983
Language proficiency Hindi , English

[krunal.patel8888]

Dear Sir / Madam Re: Application for Clinical Research Associates I am writing to express my interest in securing a Clinical Research Associates position with your firm, in response to your job posting in internet. I am currently employed as Quality Control Officer at BA Research India Limited. Now I found your esteem concern for proliferate my knowledge and idea for betterment of me and same time dynamically, I may help to enrich your organization for progress with optimization. In that regard, I would appreciate the opportunity to meet with you to discuss my qualification and the possibility of joining your organization. Please find my enclosed resume for your review. I look forward to be hearing from you. please find my Resume, Patel Krunal Vrajlal B-64, Ajay Tenament part-4, Amraiwadi, Ahmedabad-380026 Gujarat, India. Phone: 9510669600 Email: krunal.patel8888 AT yahoo.com Career Objective:- Seeking a result oriented company having a globally competitive environment that is Looking for an ambitious and career conscious person, where a blend of my acquired Skills and education will be utilized on challenging assignments in a creative Atmosphere, using innovative technologies that shell out a steady-paced professional Growth to my organization & me. Academic Performance: Completed B.Pharm from L.M.College of Pharmacy - Gujarat University in 2009 Qualified IIT-GATE in 2009 with 87.45 percentile. Computer Credentials: I have basic computer knowledge, MS Office and internet. Personal Profile: Date of Birth: 08 Aug 1988. Gender: Male. Nationality: Indian. Languages: English, Hindi, & Gujarati. Interest: Reading, Sports, Music. Marital Status: Single Strengths: Enthusiastic, polite, and determined towards work Training Undertaken: GCP Training taken by BA Research India Ltd, Ahmedabad. EXPERIENCE: I am working as a “Junior Research Associate” as Quality Control Specialist from August 09 to till in a BA Research India Ltd, Ahmedabad. o Online Monitoring and Review of Clinical Study Raw data. o Review 100% of clinical raw data and ensure the quality and integrity of data. To ensure completeness of documentation pertaining to a study. o Review of QC-SOPs. o Maintain QC-Review records. o Ensure acceptance criteria for applicable parameters are met as per Protocol and relevant SOP and properly reflected in the raw data. To report any deviations to the Quality Group in charge. o Hard copy archiving of study raw data. o To check clinical study report prepared by report team person. o Sound Knowledge of different Regulatory bodies of clinical research like ICH-GCP, FDA Guideline, Canadian Guideline, Indian GCP, etc. DECLARATION: I here by declare that all the statements made above are true, complete & authentic to the best of my knowledge & belief. yors faithful, Krunal

[Guest]

RESUME
Jayshil A Bhatt.
B.Pharm
Mobile : (91)
E-mail : jayshilbhatt AT yahoo.co.in
________________________________________________________
Career Objective
Seeking for an opportunity in the Pharma R&D/ Regulatory and to utilize my skills in the
preferment of the organization.
WORK EXPERIENCE SUMMARY
Presently working as a Quality Control Officer in Claris life sciences Ltd since June 2010
Current Job profile & Responsibilities :
- To investigate failure of any finish product /out of specifications and take the
corrective and preventive actions.
- To ensure the analysis of the API product formulation
- To ensure the analysis of the finish product sample or in process product and on time
and release of it as specified under regulatory norms and in house standards.
- To carry out the calibration of the analysis instruments as per the schedule.
Technical Skills :
Very well versed with handling and operation of following Analytical Instruments.
- HPLC, GC, AAS ,UV, LPC,
- AQUZIZER MASTERSIZER, LYPHOLIZER,
- OXYGEANALYZER,
- PH-METER, CONDUCTIVITY METER,
- VOLTAMETER TOC, POLARIMETER And Auto-Titrate
INDUSTRIAL TRAINING / INTERNSHIPS
1). M/S Amneal Pharmaceutical Company Pvt.Ltd,
Department : Formulation & Development Department
Duration : 45 Days
2). M/S SWISS PARENTALS Pvt .Ltd,
Department : Production and Quality control department
Duration : 45 Days
Correspondence address :
4 Shiv Shakti soc,Nr aavkar hall,
Ghodasar, Ahmedabad – 380050
Phone : +91(079) 25396380
Educational Qualifications :
YEAR Board / University % Year of
completion
B.Pharm 4th Year
Gujarat University
61.35 2010
B.Pharm 3rd Year 62.5 2009
B.Pharm 2nd Year 57 2008
B.Pharm 1st Year 57.36 2007
HSC Gujarat State Education
Board
73.40 2006
SSC 82.43 2004
Academic Achievements : 2nd Rank winner in STATE LEVEL POSTER COMPETITION during
National Pharmacy Week Celebration 2009
Attend Seminar on Scope and Potential in field of Pharmaceutical
Research by institute of Pharmaceutical Education and Research
Pune.
Computer Proficiency : Familiar with Microsoft Office suit including MS Word, Ms Excel, Ms
Power Point.
Current CTC : 1.2 Lacs per Enum
Expected CTC : Negotiable
Notice Period : Negotiable
Strength : Creative, resourceful, presentation and marketing skills, Ability to
work as Team volunteer and as Team Leader.
Hobbies : Acquiring spiritual knowledge, writing &reading, social service, Acting and
stage performance.

[Guest]

Dear sir,

Kindly find attached resume for an application for vacant position if any in clinical research.

[Guest]

PATEL JIGNESH KANUBHAI
E-Mail : jigpharma4all AT yahoo.com
Seeking assignments in the domain of RESEARCH AND DEVELOPMNET (R&D), FORMULATION AND DEVELOPMENT (F&D) & QUALITY ASSURANCE with a growth oriented organisation of repute
AN OVERVIEW
- Completed M.Pharm (Pharmacology) with 74.43% from SCS College of Pharmacy, Rajiv Gandhi University of Health Science, Karnataka.
- 2nd year dissertation : “A STUDY ON ANTIOXIDANT AND ORGANOPROTECTIVE EFFECT OF LEAVES OF SAMANEA SAMAN (JACQ.) MERR”.
- Adaptable and a quick learner; possess skills to work under pressure.
- Instrument Exposure : Double Beam U.V. Spectrophotometer; Colorimeter and Autoanalyser.
- Proficiency at grasping new technical concepts quickly & utilising it in a productive manner.
- Believe in continuous learning and an innovative approach.
- Possess good communication skill, systematic approach and ability to work effectively in fast paced environments.
ACADEMIC CREDENTIALS
2011 Master of pharmacy (in pharmacology) from SCS College of Pharmacy, Rajiv Gandhi University of Health
Science, Karnataka. Secured : 74.43% (first Class)
2008 Bachelor of Pharmacy from SCS College of Pharmacy, Rajiv Gandhi University of Health Science, Karnataka. Secured : 65.78% (first Class)
2004 Higher Secondary Certificate from Vakhariya P.J High School, Gujarat Education Board.
Secured : 55.51% (secondclass)
2002 Secondary Certificate from Vakhariya P.J High School, Gujarat Education Board.
Secured : 78.43% (Distinction)
IT FORTE : Conversant with Windows, MS Office and Internet Applications

DISSERTATION : A STUDY ON ANTIOXIDANT AND ORGANOPROTECTIVE EFFECT OF LEAVES OF SAMANEA SAMAN (JACQ.) MERR

CONFERENCES ATTENDED
- Attend 61st Indian Pharmaceutical Congress -2009 in Ahmedabad.
- ICMR Sponcered two days national seminar on “Advanced in Drugs Design and Drug delivery for Pulmonary Diseases” – 2010 organized by BLDEA’s College of pharmacy, Bijapur, Karnataka.
- National seminar on Current Trends and Recent Advancement in Herbal Drugs–2011 organised by AYUSH(Ayurveda, Yoga with Naturopathy, Unani, Siddha and Homeopathy), New Delhi, india.
- Attend National seminar on the Recent Advances in Pharmaceutical Research organized by SCS college of pharmacy, Harapanahali. Karnataka,India.
POSTER PRESENTATION

- A Study On Drug-Drug Interaction Between Carbamazepine And Rosiglitazone In Normal And Alloxan Induced Diabetic Rats. In 61st Indian Pharmaceutical Congress -2009 in Ahmedabad.
PAPER PUBLICATION

- Study of Antioxidant And Nephroprotective Potential of Leaves of Samanea
Saman (jacq.) Merr.
- Study of Hepatoprotective Potential of Bark of Samanea saman (jacq.) Merr with Emphasis On the Determination of Total Phenolic And Flavonoidal Contents.
AFFILIATIONS
1) Member of Gujarat Pharmacy Council of India (PCI)
2) Member of Association of Pharmaceutical Teachers of India (APTI)
3) Member of Indian Pharmacists Association (IPA)

INSTRUMENTATION PURVIEW
- Double Beam U.V. Spectrophotometer
- Autoanalyser
- Dissolution apparatus
- Friability tester
- Disintegration apparatus