www.aurolabs.com Auro Laboratories Ltd Mumbai : Regulatory Executive

[mskavi]

Auro Laboratories Limited
http://www.aurolabs.com

Company Profile
We are manufacturers and exporters of Pharma bulk drugs. The head office is at Mumbai and the plant is situated at Tarapur. The facility operates as per international cGMP standards and the company has regulatory approval (COS) for its products.


Regulatory Executive
Auro Laboratories Limited

Experience:
5 - 10 Years
Location:
Mumbai
Education:
UG - B.Pharma - Pharmacy

PG - M.Pharma - Pharmacy
Industry Type:
Pharma/ Biotech/Clinical Research
Functional Area:
Healthcare, Medical, R&D
Posted Date:
18 Aug


Job Description
- Preparation of departmental SOP's, protocols and validation documents
- Imparting training & implementation of documents
- Preparation of documents like DMF in CTD Format & supporting regulatory documentation of agencies like USFDA, MCA, & EDQM

Desired Candidate Profile
-Preparation of departmental SOP's, protocols and validation documents
-Imparting training & implementation of documents
-Preparation of documents like DMF in CTD Format & supporting regulatory documentation of agencies like USFDA, MCA, & EDQM


Contact Details
Email Address:
career@aurolabs.com

Telephone:
Not Mentioned

Reference ID:
Regu.Exe

Keywords: Regulatory Documentation, API

[Guest]

Monika Pandey
mnkpharma11 AT gmail.com
OBJECTIVE
To hold a Leading and satisfactory position in Research and Development field of Pharmaceutical sciences in a reputed organization and achieve a nick for self through my skill, knowledge and experience.
Looking forward to work in the formulation, regulatory or IPR departments of R&D
QUALIFICATION
Professional :
- Master of Pharmaceutical Sciences (M.Pharm) in Pharmaceutics in the year 2009-11.
SGPA 1st Sem. 8.5
2nd Sem 8.3
M.Pharm project work (3rd) sem.SGPA-9.8
Gupta College of Technological Sciences,Asansol,West Bengal
West Bengal University of Technology, Kolkata
- Bachelor Pharmaceutical Sciences (B.Pharm)
Gupta College of Technological Sciences,Asansol,West Bengal
securing aggregate 8.63 CGPA, West Bengal University of Technology, Kolkata
Academic :
- 70% in 2004 10+2 from CBSE, Patna ,Bihar
- 87% in 10 th from CBSE, Ranchi, Jharkhand
Achivement
Qualified GATE-2009 with 90 percentile.
ACADEMIC PROJECT (M.Pharm Project Work)
Title : Formulation And Development of Corticosteroid Gel as per ANDA strategy.
Organization :
Pharmaceutical Technology Center (R&D), Zydus Cadila Healthcare ltd.,Thane,Maharashtra.
Project :
1 : API characterisation
- Particle size determination
- Identification by HPLC and IR Spectrophotometer
- Melting point determination by DSC
2 :Innovator characterisation
- Invitro Diffusion Study
- Related substances and impurty profilling study
- Assay determination
- Viscosity determination.
3 : Preformulation Study
- Excipient selection
- Excipient compatibility study
- Methodology, Process and Procedure selection for fomulation development.

4 : Formulation and Development Trials
- Formluation evaluation to match invitro diffusion study.
- Formulation evaluation to match viscosity.
- Formulation evaluation to control impurities.

ACADEMIC INDUSTRIAL TRAINING
Accomplished one month of industrial training from Gardian Laboratories ltd,Kolkata in liquid oral and Oral solid Production Division.
INSTRUMENTS HANDELED
- IR Spectrophotometer
- Brookfield Viscometer
- Ika Homogenizer
- Tripple Roller Mill
- Tablet Compression Machine
- Tablet Coating Machine
- Fluidized bed granulator
- Disintegration apparatus
- Bulk density-Tap density apparatus
- Friabilator
- LOD apparatus
SEMINAR PRESENTATIONS
- Preformulation
AREAS OF INTEREST AND SKILLS IN PHARMACEUTICALS
Formulation and Development,Intellectual Property Right, Drug Regulatory Affairs, Corporate Quality Assurace.