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[QUOTE=Guest-IJT;122530][b]Name [/b]: Yogita Sitaram Tambe
[b]Email [/b]: gttmb9 AT gmail.com
[b]Designation / Skillset[/b] : Regulatory Affairs Executive 
Application for post of Regulatory Affairs Exe.

[u][b]Resume[/b][/u] :
YOGITA S. TAMBE 
________________________________________________________________________________________________________
[b]Career Objective [/b]:
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.
[b]Current Experience [/b]:
Presently working in Cipla Ltd. (Vikhroli) in Product Registration Cell dept. as
Regulatory Affairs Officer from Jan.2009 till date.
[b]Roles & Responsibilities [/b]:
[b]Countries handling [/b]: 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.
..
[b]Previous Experience  [/b]:
Experienced in Quality Assurance department in Manesh Pharmaceutical Ltd,
Govandi, Oct.2007 to Jan.2009.
[b]Roles & Responsibilities [/b]:
- 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.
[b]- Documentation [/b]: Preparation of BMR, BPR, MFR, Standard Operating Procedures,
 Summery sheet of batch mfg record, etc.
- Checking & maintaining various records, registers, Log books.
[b]- Validation [/b]: Coordination with Validation activities, preparation of validation protocol
 And Reports.
[b]- Sampling [/b]: Sampling at Mfg, in-process and at packaging level. Collection of control
 Samples, Stability samples, Validation samples, and Q.C. samples for analysis.
[b]- Training [/b]: 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.
[b]Inplant Training [/b]:
In plant training in Mayer Organic, Thane [Production (Tablets, capsules), Quality
Control] for one month.
[b]Extra Curricular Achievements [/b]:
- Participated in College level seminars.
- Actively participated in college level singing, Drama competition, Essay Competition.
[b]Educational Qualification [/b]:
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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