www.altreelab.com Altree Healthcare Cochin : Medical & Regulatory Affairs

[muthukalee]

Is a career in clinical research right for you?

Application Policy : ALTREE HEALTHCARE is an equal opportunity employer and offers competitive salaries and benefits, a challenging and exciting work environment, and the opportunity to be at the forefront of health research for the 21st Century. ALTREE HEALTHCARE accepts electronic applications for full, part-time or co-operative student employment on an ongoing basis. If you are interested in a career with ALTREE HEALTHCARE, please send the CV to HR address. You will be notified immediately of the receipt of your application and will be contacted by a ALTREE HEALTHCARE human relations officer if your qualifications and expertise fit our current requirements.

Areas of Opportunity :
* Clinical trials management
* Clinical data management
* Biometrics and statistics
* Information technology
* Medical and regulatory affairs
* Finance and human resources

* Interested candidates are requested to send their : CVs to hr@altreelab.com

About us :
Altree Healthcare, a division of ALTREE HEALTHCARE Pvt. Ltd was established in the year 2006, by a group of professionals from the Healthcare industry with rich & varied experience at Corporate levels. Built as an extremely professional organization, we are obsessed with quality, creativity, time committed and display thorough professionalism in whatever endeavor we undertake. Our key service areas include Site Management Services, Clinical data management, Clinical Research Training, Consulting for Corporate firm and investigators.

Contact us :
Altree Healthcare
A divison of ALTREE LAB Pvt. Ltd.
Bldg No. 35/1986 B1
Opp. IMA House
Nehru Stadium Road
Palarivattom – Cochin 25
Kerala – India 682 025

http://www.altreelab.com/

[Guest-IJT]

Name : Yogita Sitaram Tambe
Email : gttmb9 AT gmail.com
Designation / Skillset : Regulatory Affairs Executive
Application for post of Regulatory Affairs Exe.

Resume :
YOGITA S. TAMBE
____________________________________________________________________________________________________ ____
Career Objective :
To seek a challenging job in a growth oriented company offering advancement, personality
& Professional development where I can learn, improve & fully utilize my abilities to take
Part in Building the organization & thus, be an asset to the organization.
Current Experience :
Presently working in Cipla Ltd. (Vikhroli) in Product Registration Cell dept. as
Regulatory Affairs Officer from Jan.2009 till date.
Roles & Responsibilities :
Countries handling : Iraq, Kurdistan, Tanzania , Madagascar, Kenya, Sudan
- Checking and compiling the documents required for preparation of dossiers such
As BMR, BPR, MFR, SPS, Stability studies, RM, API specification & COA, FPS,
Validation reports etc.) And all other product information require for regulatory submission.
- Coordination with different departments like R & D, Production, ADL, QA, QC Medical, Export, Purchase & Packaging Development departments etc. for arranging
Documents required for preparation of dossiers.
- Preparation & Submission of Dossiers to countries which are mentioned above.
- Preparation of dossiers such as new registration, Site change dossiers,
Re- registration dossiers according to regulatory requirements.
- Handling & timely responses to queries related to Product Registration received from Regulatory bodies.
- Checking and Approving the Artworks, CMCL, SPMS raised by Packaging
Development Dept.
- Giving application of Licenses, Certificate of Pharmaceutical Product, Free Sale
Certificate, Export Certificate to respective FDA dept. as per registration
Requirements.
- Carrying out the any task delegated by HOD/ Senior Regulatory Affair Executive.
- Preparation and submission of Tender documents of the Products for different Countries.
..
Previous Experience :
Experienced in Quality Assurance department in Manesh Pharmaceutical Ltd,
Govandi, Oct.2007 to Jan.2009.
Roles & Responsibilities :
- Worked in different dosage form such as Tablets, Capsules, Ointment, Cosmetic,
Injection.
- Monitoring the IPQC activities at different stages of manufacturing, packaging operation.
- Giving the Line clearance for stages like Dispensing of raw materials, Manufacturing,
Packing, Labeling, etc.
- Dispensing of raw materials & API.
- Documentation : Preparation of BMR, BPR, MFR, Standard Operating Procedures,
Summery sheet of batch mfg record, etc.
- Checking & maintaining various records, registers, Log books.
- Validation : Coordination with Validation activities, preparation of validation protocol
And Reports.
- Sampling : Sampling at Mfg, in-process and at packaging level. Collection of control
Samples, Stability samples, Validation samples, and Q.C. samples for analysis.
- Training : To prepare training schedules in coordination with the other departments,
Conduct training for the college students and maintain the records of the training
And its evaluation.
- Release of the Batch through the ERP system for dispatch.
Inplant Training :
In plant training in Mayer Organic, Thane [Production (Tablets, capsules), Quality
Control] for one month.
Extra Curricular Achievements :
- Participated in College level seminars.
- Actively participated in college level singing, Drama competition, Essay Competition.
Educational Qualification :
Qualification
Year of passing Institution Board/University Percentage
B. Pharmacy 2007 C.U.Shah College of Pharmacy S.N.D.T University ,
Mumbai
64.00%
H.S.C
2003 K.J.Somaiya College Maharashtra Board
68.50%
S.S.C 2001 Chembure High School Maharashtra Board
75.33%
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More Information about this submission and submitter:-
___________________________________________________
Submission ID : 4291101
Date & Time : 23rd Jun 2011 2:34 PM (UTC)
IP Address : 14.97.97.9
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