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[QUOTE=Guest;169471]DHANJI LIMBASIYA
 dhanjilimbasiya AT yahoo.com 
OBJECTIVE
To work for a company that harnesses my potential to the fullest so as to help in its overall development and to aspire to excel in the field of Research and Development and widen the horizons with respect to the applicability of my role in variety of challenging business situation particularly in a global scenario.
Job Profile
At Astra Lifecare (India) Pvt. Ltd, 100% EOU
- Preparation of registration dossier as per various countries’ i.e. Kenya (CTD Format) Srilanka, Uganda, Tanzania, Venezuela, Ethiopia and Congo regulatory requirements for registration of product.
- Preparation of Master format as per country’s regulatory requirement guideline.
- Requisition to various department for required documents and follow up for the same.
- Review of documents, compilation of dossier documents.
- Handling of queries i.e. any additional requirement from various countries.
- Legal work i.e. Application for the product permission, Free Sale certificate and Certificate of Pharmaceutical Product to FDA and/or DCG (I).
- Communication for Bioequivalence data.
- Trademark Application and follow up of same.
At Amneal Pharmaceuticals (India) Pvt. Ltd
- Regulatory compliance related work wiz. Preparation and review of regulatory related documents for ANDA filing in accordance with eCTD format.
- GLP compliance in accordance with USFDA guideline
At Troikaa Pharmaceuticals Ltd.
- Preparation of registration dossier as per various countries’ regulatory requirements for registration of product.
- Review of documents like MFC, BMR, BPR, MPD, Specifications, Analytical Method Validation Protocol and Report, Process Validation Protocol and Report, Stability Protocol and Report, Product Development Report with respect to requirements of various regulatory agencies i.e. Europe as well as other agencies like Malaysia, Thailand- Asian Countries, African countries, Central America, Colombia, Azerbaijan, Belarus, Bolivia, Chile, Cambodia, Domician Republic, DR Congo, Franchophone, Sudan, Kenya, Philippines, Indonesia, etc.
- Communication with various departments regarding availability of documents required for registration within defined timeline.
- Justification of various deficiencies raised by regulatory agencies of aforementioned countries.
- To maintain registration amendment status and implementation of those changes in related documents.
- To maintain product registration status for various countries.
- To check feasibility of documents for dossier submission.
Professional Experience
Present Organization
Astra Lifecare (India) Pvt. Ltd, 100% EOU March-2011 to till date
[b]Designation [/b]: Executive-IRA
- Preparation of registration dossier as per various countries’ i.e. Kenya (CTD Format) Srilanka, Uganda, Tanzania, Venezuela, Ethiopia and Congo regulatory requirements for registration of product.
- Preparation of Master format as per country’s regulatory requirement guideline.
- Requisition to various department for required documents and follow up for the same.
- Review of documents, compilation of dossier documents.
- Handling of queries i.e. any additional requirement from various countries.
- Legal work i.e. Application for the product permission, Free Sale certificate and Certificate of Pharmaceutical Product to FDA and/or DCG(I).
- Communication for Bioequivalence data.
- Trademark Application and follow up of same.
- To maintain registration amendment status and implementation of those changes in related documents.
- To maintain product registration status for various countries.
- To check feasibility of documents for dossier submission.
Amneal Pharmaceuticals (India) Pvt. Ltd July 2010 March 2011
[b]Designation [/b]: Executive (Reviewer)-ARD
- Preparation and Review of Regulatory documents. Viz. Specifications API, Finished product as well as excipients, Analytical Procedures, Analytical Method Validation protocol and report, justification of specification, Reference standard and Material, Stability summary and conclusion, stability data, Post approval stability protocol and commitment
- GLP compliance related work in accordance with USFDA.
[b]Troikaa Pharmaceuticals Ltd., Thol, Mehsana, Gujarat. May 2008 to July 2010 Designation [/b]: Sr. Officer (QA/RA)
- Preparation of registration dossier as per various countries’ regulatory requirements for registration of product.
- Review of various documents for product registration in Europe as well as Malaysia, Thailand- Asian Countries, African countries, Central America, Colombia, Azerbaijan, Belarus, Bolivia, Chile, Cambodia, Domician Republic, DR Congo, Franchophone, Sudan, Kenya, Philippines, Indonesia, etc. 
- Preparation of validation and qualification protocol and execution of various validation and qualification activity viz, HVAC System, Autoclave, Dry Heat Sterilizer, Process validation of Parenteral and Tablets Manufacturing process, Purified water and Water for Injection generation and distribution system, Compressed Air and Nitrogen generation and distribution system, Visual Inspector for Parenteral as well Tablet & Capsules.
- Independently executed all qualification and validation activity for newly established plant of Troikaa Pharmaceuticals at Dehradun.
- Worked in In Process Quality Assurance in Sterile Manufacturing as well as oral dosages manufacturing i.e. Tablet as well Capsule.
Educational Qualifications
- Completed M. Pharm with specialization in Pharmaceutical Chemistry in March 2008 from Lachoo Memorial College of Science and Technology, Jodhpur, Rajasthan.
- Completed B. Pharm in June 2004 from L. M. College of Pharmacy, Ahmedabad, Gujarat.
Computer Proficiency
- Oprating Systems- Windows Vista, Windows XP
- Software- ISI Writer, MS Office 2007 and 2003 (MS word, Excel, PowerPoint and MS-Access), Adobe Acrobate Professional 6.0 and 9.0
Skills
- Experience of preparing documents in eCTD format.
- Good knowledge of eCTD and ACTD.
- Good knowledge of GMP, GLP, EU and USFDA guideline. 
- Good communication skill with a penchant for hard work coupled with a positive attitude
- Effective Team Worker and punctual
 
INTERESTS\ HOBBIES
- Listening to music, dancing and travelling.
- Playing cricket, volley ball and playing all outdoor games.
- Reading Novels and Brain Teasing Puzzles.[/QUOTE]

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