SIRO Clinpharm Pvt Ltd Mumbai : Medical Writer

[muthukalee]

Medical Writer

Impart knowledge under supervision and perform clinical communication activities and contribute to medical reports in a continuous learning environment.

The incumbent should be MBBS, BHMS, BAMS, MD, Ph.D. or Post graduate in Pharmacy or life sciences with at least one year experience in MW with an ability to interpret and analyze data.

The core responsibilities for the position would be:
* Development of Clinical Study Reports, protocols, ICFs, Ibs, Narratives, safety Reports, Efficacy Reports, Publication manuscript, abstract, poster, presentation, training kit, product toolkit, white paper, etc preparation & compilation of Dossiers and other regulatory submission documents
* Ensure that documents are approved and issued in accordance with standards & timelines
* Performing quality check review of above documents
* Performing literature search
* Documentation and archival for above deliverables

To apply, please send your CV to hr_India@siroclinpharm.com with “Job code” clearly mentioned in the subject line along with your “location” preference.

For example, candidates who wish to apply for Data Manager positions in Mumbai should send their CVs with the subject line – 02/08/DM and Mumbai.

About us:
SIRO Clinpharm is a leading full service Clinical Research Organization that specializes in providing solutions to the twin challenges of speed and cost in clinical drug development.

Contact us:
SIRO Clinpharm Pvt Ltd
DIL Premises, Swami Vivekanand Road,
Near Tatvagyan Vidyapeeth, Ghodbunder Road,
Thane (W) 400 610,
India

http://www.siroclinpharm.com

[Guest]

job application

[Guest-IJT]

Dear Sir/Madam,
Myself is Mrs.Supriya Patil from Aurangabad.PI have completed my M.Sc in Biochemistry from North Maharashtra University,Jalgaon & presently working in Wockhardt Biotech park Ltd,Aurangabad.I am sending you my resume for your information.kindly go through it. Please have kind consideration of my resume if you have any job opportunity matching with my profile.
Thanks & Regards/-
Mrs.Supriya Patil.


RESUME

SUPRIYA PRAVIN PATIL
Seeking middle level assignments in R&D/ Quality Control/ Regulatory Affaires/ Quality Assurance with a reputed organization in the Pharmaceutical Sector

PROFESSIONAL ABSTRACTS

Post Graduate in Biochemistry with over 6 years of experience in Quality Control, Stability Study and Compliance Management. Currently serving as Executive – Quality Control with Wockhardt Biotech Park Ltd., Aurangabad. Deftness in handling stability study documents, quality system documents, regulatory documents, cGMP documents. Proven abilities in effectuating for preparedness of facing any time regulated audits. Effective communicator with excellent relationship management skills; process a result oriented attitude with analytical skills.

EDUCATIONAL QUALIFICATION:-

Qualification Details Board/University Year of Passing Percentage
M.Sc.(Biochemistry) North Maharashtra University, Jalgaon 2004 64.4%
B.Sc.(Chemistry) North Maharashtra University, Jalgaon 2002 63.0%
H.Sc. Nasik Board 1999 66.0%
S.S.C. Nasik Board 1997 61.0%

ADDITIONAL QUALIFICATION:-

FDA certified for Chemical and Instrumental Analysis.

EXTRA CURRICULAR ACTIVITIES:-

1) Carried out project work on, “Surveillance of Diabetic Patients in Jalgaon City”, as a partial fulfillment for M.Sc. programmer.
2) Conducted Seminar on, “Cryopreservation Techniques and its Applications”, as a partial fulfillment of M.Sc. Programme.
3) Passed MS-CIT examination with 77% marks.
4) Passed ‘C’- Programming with ‘A’ grade.

EMPLOYMENT SCAN


Feb-2010- till date Wockhardt Biotech Park LTD, Aurangabad, Executive- QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at different locations in Aurangabad and rest of India, it sets up a 100% Export oriented Insulin & Erythropoietin API, Sterile and Formulation facility in Aurangabad to meet the requirement of its customers in USA, Russia, Columbia and other European markets. The company is certified with US-FDA,MHRA,TFDA, Colombia INVIMA & WHO-GMP. Also the company has its well equipped and modern R&D center in Aurangabad.
Job Profile:
- Analysis as well as documentation of API Bulk, Inprocess samples and Stability Products.
- Preparation, analysis as well as documentation of Working Standards.
- Reviewing of analytical data.
- Responsible for GLP related documents.
- Preparation of Specifications, STPs & SOPs.

June - 2006 to Feb-2010 Orchid Chemicals & Pharmaceuticals Ltd. Jr.Executive-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at different locations in an around Aurangabad and Chennai, it sets up a 100% Export oriented Ultramodern API, Sterile and Granulation facility near Chennai to meet the requirement of its customers in USA, Australia, Africa, Canada, Japan and other European markets. The company is certified with US-FDA, MHRA, and ISO: 140001OHSAS, ISO9001:2000 Environment management Quality Certification, Danish Medical Agency.
Job Profile:
- Analysis as well as documentation of Stability Products as well as Holding Time Study Products.
- Preparation, analysis as well as documentation of Working Standards.
- Up-gradation of Stability Study Summary Data Sheet as per Regulatory Affaires.
- Preparation & up gradation of Stability Calendar.
- Preparation of Stability documents as per US-FDA, MHRA & cGMP norms.
- Well familiar with SAP system (QM - Module).
- Daily monitoring of Temperature & Humidity of Stability Chambers [Make: - Newtronic Equipments; Software: - ICDAS Ver-2.1Data-Loggers].
- Partially working in Review / Compliance team, for review of Documents [Finished products, Reaction monitoring, IPQC docs, etc] and handling quality system documents like; OOS documents, Change Control, deviations, Laboratory investigations and OOT study in Stability studies.
- Preparation, Co-ordination and implementation of SOPs, specification, STP and various types of Formats related to SOP.
- Coordinating with R&D and PD Lab for Stability and Holding Time Study related issues.
- Coordinating with Regulatory Affaires and fulfilling their requirements with respect to filling of new drug products and annual updating.

Dec- 2005 to June- 2006 Midas Care Pharmaceuticals Pvt Ltd., Aurangabad Sr.Officer-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at Aurangabad, it sets up an Export oriented Formulation facility and pioneer in Aerosol technology (MDI-preparations). The company is certified with US-FDA, MHRA, TFDA, and Brazil Anvisa.
Job Profile:
- Handled analysis and documentation of Raw Materials.
- Analysis and documentation of Bulk & Finished Products.
- Maintenance of Control Samples as per their storage condition and packing configuration.
- Maintenance of Chemical entry register & Glassware Calibration as well as record making.
- Analysis and documentation of on-going Stability of Finished products.
- Sound knowledge of Safety norms followed during handling of Lab chemicals and Steroids.

June- 2004 to Nov- 2005 JCPL Pharma Pvt.Ltd, MIDC, Jalgaon Officer-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at Jalgaon, it sets up an Export oriented Formulation facility. The company is certified with ISO: 9001:2000 Quality Certifications
Job Profile:
- Chemical analysis of raw material as well as Intermediates and Finished Product.
- Handled Stability testing of Product.
- Preparation, Maintenance and Record keeping of volumetric solutions and other Laboratory Reagents.
- Instrumentation analysis of raw material and Product.
- Inventory control of lab chemicals and record keeping.

May- June 2003 Blue Cross-Laboratories Pvt.Ltd, Nasik Inplant Trainee-Quality Control
Job Profile:
- Chemical & Instrumental analysis of Raw material and Finished Products
- Basic Microbial Techniques.


Instruments Handled:

- H.P.L.C (Agilent 1100 and 1200 series) (Software: Chemstation)
- R.R.L.C (Agilent 1200 series) (Software: EZ-Chrome elite)
- H.P.L.C (WATERS 2650 series) (Software: Millenium2000 & Empowers2)
- H.P.L.C. (Shimadzu) (Software: Class-VP).
- Spectrophotometer (Perkin Elmer Lambda650 & Lambda25 & Cientra 10e)
- KF Autotitrator (Swiss made Metrohms)
- AAS (GBC 932 Plus) (Software: GBC Avanta)
- Rudolphs Autopol Polarimeter.
- Well versed with operating systems like Windows 2003 & Windows XP Professional and software packages like MS-Office Word & Excel.

Preferred Location: - Aurangabad, Nasik and Pune.


PERSONAL INFORMATION:-
DATE OF BIRTH : - 2nd April 1982
MARITAL STATUS : - Married

Personal Skills

- Sincere, Self-motivated, hard working & capable of working in deadliness.
- Team player can motivate others to achieve objectives.
- Effective communicator can interact at all hierarchy levels effectively.
- Anxious to learn new things.

LANGUAGES KNOWN:-
Can speak and write fluently in English, Marathi and Hindi.

I declare that the information given above is true to the best of my knowledge.

Place: -
Date: -

(Patil Supriya Pravin)

[Guest]

E-mail : bijal.siroya AT gmail.com
BIJAL.B.SIROYA

Career Objective :
In this competitive world, I strive to give my best performance in all aspects of life. I wish to join an organization that will provide a challenging work environment and would best address the capabilities that I have gained through my education to add value to the organization and myself.
Experience : 2nd June 2009 – Till Date
Bharti AXA Life Insurance Company, Jogeshwari (W), Mumbai
Designation : Executive - Medical Underwriter
(Department – Underwriting)
Languages : English, Gujarati, Hindi and Marathi.
Profile :
- Underwriting medical & non-medical cases .
- Making decision based on the information received from the proposal form and other relevant documents.
- Processed high value Medical and Non-medical cases.
- Attending branch queries related to underwriting via mails to branches across the country.
- Giving inputs on any process developed.
- Mentoring new joinees with u/w guidelines, processes and systems.

2) Limits & Authority :
Financial Sum Assured up to 30Lacs-Non-medical & up to 10Lacs-Medical

3) Additional Responsibility :
TPA (Third Party Administration)
- Maintaining TPA register on daily basis for Monthly MIS Preparation (responsible for updating the records of all cases sent to TPA and decisions received for individual life) within TAT.
- Following up and Co-ordinating with respective TPA for the Referred cases .
ABS Auto/Manual QC :
- Quality check of the cases, which are processed at ABS.
Risk Control Unit (RCU) :
- Maintaining Risk Control Unit (RCU) register on daily basis (records of all cases send to RCU and decisions received) within TAT.
- Handling internal and external customer, helping to resolve queries within defined timelines-RCU queries.
- Ready reckoners and User manuals drafted for easy reference.
- Worked on UATs for system enhancements as per requirements.
- Processing the cases for Reinstatement within TAT and preparing the
final MIS of the same.
- Decilned/postpone letters QC of ABS : maintaing daily check of the Declined/postpone letters generated by ABS and simultaneously preparing monthly
MIS of the same.

Experience :
* Underwent practical training for one month at U.S.Pharma in Quality Control and also observed production in following departments :
1. Tablet 2.Capsule 3.Liquid Syrup 4.Ointment
* Worked part time at Radiation Research Malad(E) as Marketing Executive and Data Entry Operator
* Attended Association of Insurance Underwriter’s (AIU) seminar for 2 days.
Academic Qualifications :
SR.
NO CLASS BOARD/UNIVERSITY AGGREGATE
1 SSC
Maharashtra Board (Matruchhaya high school) 82.93%
2 HSC(Science)
Maharashtra Board (Mithibai college) 73.33%
3 F.Y.BPharm S.N.D.T.Womens University (C.U.Shah college) 70.08%
4 S.Y.BPharm S.N.D.T.Womens University (C.U.Shah College) 70.79%
5 T.Y.BPharm S.N.D.T.Womens University (C.U.Shah college) 67.38%
6 Final.Y.BPharm S.N.D.T.Womens University (C.U.Shah college) 71.42%
Professional Qualification :
- Have cleared Licentiate examination.
Training and Project Work :
- Undertaken Industrial Training For one month at U.S. Pharma at Bhiwandi-Wada Road, Thane District.
Final Year Project : Biofilms at C.U.Shah College of Pharmacy.
Extra Co-Curricular Activities :
- Have participated and won at inter school,ward and College level in Folk Dance, Elocution, Poem, Essay and Singing Competitions.
- Have participated in the FASHION SHOW 2006 and 2007 at RX
- Have participated in the Dance, Essay and Elocution Competitions at the S.N.D.T. Yuva Festival.
- Have participated in the SCIENCE EXHIBITIONS at the ward level.
- Have Participated in Training Centre for the cause and welfare of the Handicapped.

[Guest]

Jyoti Prakash
Email id : ramawatjp AT gmail.com

Objective : Looking forward for a career that provides an opportunity to grow as a successful professional, achieve optimum working environment that allows me to put the best of my knowledge to application and to implement the knowledge gained thereby for further development of the organization effectively and efficiently.
Clinical research knowledge and skills :
- Clinical research fundamentals
- ICH-GCP and Indian GCP
- Clinical trial designing
- Project planning and management
- Study startup process
- Clinical monitoring and essential document compliance
- IEC/IRB submission or notification procedure
Experience : 3 months as a clinical study coordinator.
Job Duties & Responsibilities :
- Ensuring the clinical trial is conducted as per ICH GCP and study protocol
- Design and maintain organizational tools to conduct trials accurately
- Train other site personnel to understand and implement the protocol
- Help PI to recruit and screen potential study participants according to the protocol’s inclusion and exclusion criteria.
- Schedule study participants’ visits and perform defined activities of the study completely and accurately during the study participant’s visit
- Preparation & subsequent submission of study related documents to the Ethics committee for approval
- To complete accurately case report forms (CRF) and maintain the source documents for each study participant and record pertinent information and data required as per the study
Qualification :
- Advanced Post Graduate Diploma in Clinical Research from Imperial Institute of Clinical Research, Ahmedabad.
Class Board/University Marks
B.Sc. Biotechnology University of Rajasthan 67.98%
12th RBSE, Rajasthan 54.62%
10th RBSE, Rajasthan 66.50 %
Project undertaken :
Name of the project Project guide Year
Tissue culture studies on Hardwickia- binata. Dr. Tarunkant (Scientist E) July 2010 to sept. 2010
Diagnosis of Tuberculosis Dr. Amit Sharma Aug. 10 to Nov. 10 2010

Worked as study coordinator in
phase III
clinical trial of traveler’s diarrhea

Dr. Sanjay Gupta
(MBBS)
Oct. 2011 to Dec. 2011

Audit Experience :
- Faced 2 times Sponsor’s Audits in 1 project .
- There were no major & critical findings in the Audit
Skills :
- Good interpersonal, site management and relationship building, verbal and written communication skills including excellent presentation skill
- A flexible attitude with respect to work assignments, willingness to learn; travel (overnight, weekend and occasional international travel).
- Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of team work
- Able to take initiative and work independently
- Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements
- Comprehensive knowledge of IP accountability, Electronic Data Capturing
Other Skills :
- Operating system : Windows XP, Windows 07, Windows vista
- Software : MS. Word, MS. Powerpoint, Adobe photoshop, Basic Internet
- Linguistic : English, Hindi, Rajasthani
Achievements : I got second rank in state, in a spiritual exam (geeta-gyan).
I participated in a district level seminar on AIDS

[Guest]

do u write individual thesis in psychiatry?