Regulatory Affairs Officer Mumbai : Medley Pharmaceuticals Ltd

[mskavi]

Medley Pharmaceuticals Ltd. Mumbai, Mumbai Suburbs : Officer- Regulatory Affairs

Website: http:// www.medleylab.com

Keywords: OFFICER REGULARORY AFFAIRS

Designation: Officer- Regulatory Affairs
Experience: 3 - 5 Years
Location: Mumbai, Mumbai Suburbs
Education:
UG - B.Pharma - Pharmacy
PG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 18 Mar

Job Description:
Preparation of Dossiers for Various countries Including CTD format.Exposure To Regulatory requirements of CIS and Regulated mkt.Interpretation & compilation of data for Dossiers.Exposure to New Product Development.

Desired Candidate Profile:
Exposure to QA documtn.Familiar with ISO/ WHO/MHRA/USFDA documentation.Hands on exp.in quality mgmt.Ability to co-ordinate with Int’l./ Internal –Ext customers.Co-ordination with Factories/R&D for documents & Samples, Art work preparation

Company Profile:
We are a progressive ISO 9001:2000 certified pharmaceuticals company and one of the fastest growing companies amongst the top 50 in the country as per ORG-IMS.

Executive Name: Ms. Sanketa Pednekar

Address:
Medley Pharmaceuticals Ltd
Medley House,
D-2, 16th Road, MIDC Area,
Andheri (E),
Mumbai,Maharashtra,INDIA 400093

Email Address: hr@medleylab.com

Telephone: 91-22-30887777

Keywords: OFFICER REGULARORY AFFAIRS

[Guest]

I did my Msc in Biotechnology.I have done clinical research and data management with Statistical Analysis System.i am looking a job in clinical research

[vrushali.sannapuri]

NOT APPLICABLE

[Guest]

Dear Sior,
Myself Nidhi Gor, B.Pharm graduate and having 4 years experience as Officer Quality Assurance.
My Job profile is Review of Batch Manufacturing Records, Batch Packing Records, Master Formula Records both for Manufacturing and Packing, Standard Operating Procedures. Preparation of Draft Label. Review of Artworks. Review of Stability records.
Herewith i m forwarding my resume
will wait for your favourable response
APPLICATION
NIDHI NISARG GOR
PERMANENT ADDRESS : PRESENT ADDRESS:
Nidhi Nisarg Gor
E.mail :nidhi_kh9 AT yahoo.com
Subject : - Application for suitable post in your esteemed organization.
Experience :-4 years’
Current designation : - QA- Officer

Organization : - Troikaa Pharmaceutical Ltd, Thol
Educational Qualification : - B.Pharm (Bachelor of Pharmacy).

Respected Sir,
I, undersigned Nidhi N Gor working with Troikaa Pharmaceutical Ltd, Thol would like to apply for a suitable post in your esteemed organization. If an opportunity is given to me, I am sure that I will work hard and with my experience and knowledge, I will win your faith soon. I am enclosing here my resume which is true to the best of my knowledge.

RESUME
NIDHI NISARG GOR

E.mail :nidhi_kh9 AT yahoo.com
Career Objective


To pursue a challenging career in an intellectually stimulating environment that will help me to realize my dream of technical innovations in the field of pharmaceutical science.
Educational Qualifications
Graduation (2007)
- Bachelor of Pharmacy (B.Pharm.)
From : - Anand Pharmacy College, Anand
Result : 66.43% aggregate – Gold Medalist
- Higher Secondary & High School
St. Francis School, Jetpur, Rajkot
12th Standard Passing Year : 2003
Result : 84.00%
10th Standard Passing Year : 2001
Result : 80.00%
Experience

Currently working as Officer QA at Troikaa Pharmaceutical Ltd. Thol
Two and half years experiences as chemist QA at Marck Biosciences Ltd., Kheda
Job Responsibility
At Troikaa Pharmaceutical ltd. Thol
- Review of MCM,MCP,BMR,BPR, Master card
- Review of specification and method of analysis.
- Review of Process Validation (PV).
- Review of SOP
- Preparation of Draft Label.
- Review of Stability Protocols.
- Review of Artworks
At Marck Biosciences Ltd, Kheda
- In process quality checks at various stages of dispensing, manufacturing, filling, packing.
- Primary handling and investigation of market complaint.
- Primary handling of change control and deviation documents
- Taken part in validation as a team member for various equipments and in media fill.
- Final review of BMR
- Product wise preparation of Annual Product Report (APR)

[Guest]

Curriculum Vitae
Mr. HARSHAD G. PARMAR
E-mail : harshadpharm AT yahoo.co.in , harshad053 AT gmail.com


OBJECTIVE
- To work in a challenging and growth oriented environment so as to apply my technical and analytical skills for the benefit of organization.
EDUCATIONAL QUALIFICATION
DEGREE UNIVERSITY
/BOARD INSTITUTE YEAR OF PASSING %OF MARKS/CPI
M. Pharm. Gujarat
Technological University
APMCCPER,
Himatnagar
2011
8.13 / 10
GATE
IIT Roorkee
-------------- 2009 AIR-1856
(92.28 Percentile)
B. Pharm. Saurashtra University,Rajkot S.J.Thakkar Pharmacy College, Rajkot 2009 60.06%
H.S.C.
GSHSEB Vividhlaxi Vidyamandir,
Palanpur. 2005 64.14%
S.S.C. GSSEB V.J.Patel High school, Vadgam 2003 85.43%
ACADEMIC ACHIVEMENTS
- Rewarded AICTE scholarship for post graduation
- Qualified GPSC Class-II for Drug Inspector
PROFESSIONAL INTEREST
- Formulation Development (F&D) : Recent Innovations in Conventional Dosage Forms e.g.: Tablets, Capsules, Semi-solids, Powders, and Liquid etc.
- Regulatory Affairs (RA) : IND, NDA, ANDA filing, and want to work with regulatory guidelines of different countries like, USFDA, TGA, MHRA, ANVISA, ICH, WHO etc
- Intellectual Property Rights (IPR) : Filing of patents and drafting of patent claims.
- Production : Manufacturing of pharmaceutical dosage forms.
PROJECT INVOLVEMENT
- Formulation and Evaluation of Buccal Patch of Lidocaine HCl – M.Pharm project submitted under the guidance of Dr.V.M.Patel.
EXTRA CURRICULUM ACTIVITIES
- Computer knowledge : Good power on MS Excel, MS Word, MS-Powerpoint.
- Have done English spoken class.
- Got 1st prize in science fair.
- Participated in elocution competitions.
- Attended state level seminar organized by Gujarat Forest Department.
Publications
- Buccal Patch : A Technical Note; A Review published in International Journal of Pharmaceutical Science Review and Research;2010
- Recent Techniques In Nasal Drug Delivery : A Review published in International Journal of Drug Delivery and Research;2010
- Microparticulate System : A revolution in drug delivery: A review published in International Journal of Pharma Informa.2010
Posters presentations
- Poster-Formulation and Evaluation of Buccal Patch of Glyburide presented at International conference on multidisciplinary approaches for Diabetes, Jaipur, Rajasthan, India.
- Poster-Formulation And Evaluation of Microparticle of Glimepride presented at International conference on multidisciplinary approaches for Diabetes, Jaipur, Rajasthan, India.
- Poster –Stability Study of Propranolol HCl Buccal Patch presented at One Day National Seminar on Stability,Kherva,Mehsana,Gujarat.
Conference & Seminar attended

- “Formulation Stratergies for Poorly Soluble Drug”,28th March 2010 organized by Kalol Indtitute of Pharmacy,Kalol,Gujarat.
- One Day Symposium on “Experimental Design and Patents” 21st August 2010 organized by APMC college of Pharmacy Himatnagar,Gujarat.
- 59th IPC Banaras Hindu University, Varansi.
- 61st IPC Nirma University, Ahmedabad,Gujarat.
- Seminar on “Operation and Working of Brookefield viscometer” organised by APMC College of Pharmacy Himatnagar,Gujarat.
- AICTE Sponsored two days national seminar on “Application of Biostatistics and Use of Software in Pharmaceutical Research” March 28-29,2011 organized by B. M. Shah college of pharmacy, Modasa, Gujarat