www.astralifecare.com Astra Lifecare India Pvt Ltd Ahmedabad : Regulatory Affairs

[Admin]

astra lifecare India Pvt. Ltd Ahmedabad : Opening for Regulatory Affairs
Company Name: astra lifecare India Pvt. Ltd
Company Location: Ahmedabad
Designation of the vacancy: Opening for Regulatory Affairs
Company E-mail for contact: pathik@astralifecare.com
Company Website: www.astralifecare.com

Details of the job:
Qualification

B Sc/ M Sc/ B Pharm/ M Pharm

Job Profile:-
1. Preparation of registration dossiers and solving queries of Semi - Regulated Phamaceutical markets
2. Verification of Dossiers & review of documents for dossiers preparation
3. Coordination with Production, Quality Assurance, Quality Control and Formulation and Development department for timely regulatory submission
4. Solving queries by regulatory authorities and promptly replying in given time frame
5. Upgrading knowldege in line with ever changing regulatory requirements
6. Preparation & approal of various type of license from the local Food & Drug Admin
7. Excellent communication and presentation skills

CORPORATE OFFICE :
207/208, Crescent Tower,
Off New Link Road,
Andheri (W), Mumbai-400 053
T : +91-22-2674 0821/31 F : +91-22-2674 0663

FACTORY :
Plot : 57/P, Sarkhej-Bavla Highway,
Village : Rajoda – 382 220
Ta : Bavla, Dist. Ahmedabad
T : +91- 9998008876, 9924511944, 9924611944, 9924441945
F : +91- 79-26871026

[Guest]

MY COMPLETED M.Sc. WITH PHARMACEUTICAL CHEMISTRY . SO PLZ SUITABLE POST AS A MY EDUCATIONAL QUALIFICATION.

[Gunjanmodi]

RESUME
Gunjan Modi
E-mail : gunjufreedom AT gmail.com
Career Objective :
To work in an organization while I can contribute towards a long term objective utilizing my skill and abilities to their full potential while at the same time learning and unifying with the organization vision.
Project/Training Experience :
My M.Pharm project was completed by me at Analytical Development Department, Pharmaceutical Technology Center, Zydus Cadila Healthcare Ltd., Ahmedabad from June 2010 to January 2011.
- Topic : Development, Validation and Stability Indicating Assay Method for Estimation of Blonanserin by RP-HPLC in Pure Drug and Marketed Formulation.
Professional Summary :
Duration/ Experience Company Designation
February-2011 till Date Pan Drugs Ltd, Nandesari, Vadodara. Q.A / Q.C
June-2010 to January-2011 Zydus Cadila Healthcare Ltd., Ahmadabad. ADL Trainee
Area of interest :
- Regulatory Affairs
- Q. A.
- ADL
- Bio Analytical Department
Professional Skills/ Functions :
- Knowledge in basics of ANDA, MHRA and other regulatory guidelines
- Knowledge of Dossiers, IND, NDA, ISO, ICH, Validation Protocols & Regulatory consideration for Manufacturing, Loan Licensing.
- I can handle modern analytical equipments like HPLC, UV, FT-IR and Dissolution Apparatus.
- Knowledge of GMP, Validation & IPQA activities.
- Analytical method development & validation.
- Stability indicating method.
- Ensure quality compliance of the product through internal audits
- Ensure all operations in the Organization are performed in accordance with CGMP guidelines, and take records of all the documents related to Production, Quality control, as well as other Departments of the company.
- Raw material and finish product analysis.
- Sampling and Analysis of Materials (AS per IP, BP, USP, EP specification) Intermediate products, finished products and stability samples.
- Review process documents stage-wise and facilitate timely release of batches
- Perform IPQA checks during production
- Review and compile deviations and change controls
Educational Qualification :
- S.S.C. and H.S.C.
Sr. No. Name of examination Board % of marks obtained Passing under the academic sessions
1. S.S.C. Gujarat Board 82.14% 2002-03
2. H.S.C.(Science Stream)
Gujarat Board 58.66% 2004-05

- Degree in Pharmacy (B.Pharm) from APMC College of Pharmaceutical Education and Research, Motipura, Himmatnagar under Hemchandracharya North Gujarat University (H.N.G.U.).
Sr. No Name of examination University % of marks obtained Passing under the academic sessions
1. 1st year B.Pharm H.N.G.U. 57.81% 2005-06
2. 2nd year B.Pharm H.N.G.U. 58.23% 2006-07
3. 3rd year B.Pharm H.N.G.U. 59.31% 2007-08
4. 4th year B.Pharm H.N.G.U. 61.81% 2008-09

- Master in Pharmacy (M.Pharm) in Quality Assurance from Jaipur National University, Jaipur, Rajasthan
Sr. No Name of examination University % of marks obtained Passing under the academic sessions
1. M.Pharm(Q.A.) 1st Sem. JNU, Jaipur 72.50 % 2009-10
2. M.Pharm(Q.A.) 2nd Sem. JNU, Jaipur 80.00 % 2009-10
3. M.Pharm(Q.A.) 3rd Sem. JNU, Jaipur 71.50 % 2010-11
4. M.Pharm(Q.A.) 4th Sem. JNU, Jaipur Appear 2010-11
Personal Details :
Name Gunjan Ashwinkumar Modi
Date of Birth 27th November 1987
Gender Male
Religion Hindu, Modi
Nationality Indian
Marital Status Single
Hobbies Singing, Reading, Swimming
Extracurricular Activities I got the Gold medal in Gujarat state swimming competitions and participated in National swimming competitions
Participated in Fashion Show at Techno razz, 2009 held at Jaipur National University, Jaipur
Participated in various singing competitions at school and college level.
Participated in Football competitions.
Participated and won various University swimming competitions.
Conventions attended and Poster Presentation :
- Attended AICTE sponsored National Seminar at Chhattisgarh in March 2010.
- Poster Presented at AICTE sponsored National Seminar at Chhattisgarh in
March 2010.
- Poster Presented at Technorazz,2009 held at Jaipur National University, Jaipur
in December 2009
Computer Proficiency :
- Can operate MS-Office and Windows skillfully.

[Guest]

Resume
Name : Divyang Gautambhai Dalvadi

e mail :digu.divyang AT gmail.com
Hobbies :Music,Reading,Traveling,Playing,
Educational Qualification
Degree Board/University Passing Year Percentage
September 2005
September 2006
University August 2008 67.10%
Bachelor in Pharmacy,(3rd Year) Rajiv Gandhi University August 2009 66.00%
Bachelor in Pharmacy,(Final Year) Rajiv Gandhi University August 2010 64.14%
Average Percentage 66.00%

[Guest]

hemant chaturvedi kota my id chaturvedi.hemant915 AT gmail.com

[Guest]

Curriculum Vitae
CHIRAGKUMAR PATEL
E-mail : chirag_patel_9785 AT yahoo.co.in
chiragpatel1788 AT gmail.com

OBJECTIVE :
Seeking a challenging and a reward career where my professional and functional expertise, hardcore industry exposure, conceptual and analytical skills would be utilized effectively and productively, and would also like to work in an exciting and professional environment of an organization with continuous learning, development and also with growth possibilities.
WORK EXPERIENCE :
From : Sep 2007 to till date Position : Sr. Executive Regulatory Affairs
In SHELYS PHARMACEUTICALS LTD, Dar Es Salaam, Tanzania. - One of the largest and fast growing leading pharmaceutical products company in middle and east Africa. Professionally managed pharmaceuticals manufacturing company producing Tablets, Capsules, Oral Liquids, Dry Syrups, Ointments and Disinfectants including penicillin and non-penicillin products.
Shelys is now a part of Pharmacare Ltd, South Africa trading as Aspen Pharmacare one of the largest manufactures of pharmaceutical products in Africa.

JOB PROFILE :
- Regulatory Affairs :
- To handle international regulatory affairs.
- Verification and Compilation of dossier for registration submission and re-registration submission, respond the queries from NDAs for dossier registration and other regulatory requirements.
- To provide documents as per current requirement to NDAs.
- To provide technical documentation for tenders (i.e. Technical file, CPPs, FSC etc.)
- Co-ordinate with other departments to organise the activities.
- Product Master Verification :
- Existing Product Specifications, Certificates of Analysis and Product Manual against registration data.
- Verification and Compilation of Master Formula Records, Batch Manufacturing Records.
- Preparation of documentation on new product receipt and updation of the documents.
- Document issue and retrieval and maintenance of supersede documents.
- Validation :
- Verification and updation of Validation documentation (Protocols and Reports).
- Compilation of Operation and Performance Validation data includes Instruments, Machineries, Purified Water System and HVAC.
- Stability Studies :
- To create the protocols according to the requirements and maintain the stability study as per protocol.
- Regulate the process of stability study and keeping the data as per standard procedure.
- Compilation of all the results as per procedure.
- Quality Assurance :
- Development and implementation of quality system.
- Checking and maintaining BMR/BPR issuing and Batch record reviews.
- To check cGMP regulations in company.
- Annual Product Review
- Vendor Qualification
- Complaint handling
- To Provide internal training
- Formulation :
- Creation of new packing material for new products.
- To create packing material specifications for existing/new packing materials.

STRENGTHS :
Self-confidence, ability to work under pressure and achieve expected results with proven Leadership capacity, believe in team-spirit and delegation of work and achieve results as per work priorities.
Have more than 4 ½ years experience to handle regulatory affairs in :
- Tanzania
- Kenya
- Uganda
- Malawi
- Zambia
- DR Congo
- Mozambique
- Madagascar
- Mauritius
- Benin
- Togo
- Rwanda
- Burundi
- Ivory Coast
- Gabon
- Burkina Faso
- Senegal
- Guinea-Conakry
- WHO
TRAININGS :
- Attained GMP Training from ROCHE at Dar Es Salaam, Tanzania.
- Attained internal GMP training at Shelys.
- I have cleared Forensic Pharmacy exam at Pharmacy Board, Tanzania, to get registered as a pharmacist in Tanzania.
- 3 months training in EXOTIC LABORATORIES LIMITED, Godhra, India. A pharmaceutical company producing Tablets, Capsules and Oral Liquids.
QUALIFICATIONS :
Period of Study Course University / Board (College) Percentage (Class) Medium of Instruction
2002-06 Bachelor of Pharmacy
(B. Pharm) Rajiv Gandhi university of health sciences, Banglore.
(H.S.K. college of pharmacy, Bagalkot) 4th year - 70.58%
3rd year - 67.00%
2nd year - 61.33%
1st year - 60.70%

English
2001-02 H.S.C M & M Mehta High School, Godhra.
(Gujarat Secondary Education Board, Gandhinagar)
57.69% Gujarati
1999-00 S.S.C M & M Mehta High School, Godhra.
(Gujarat Secondary Education Board, Gandhinagar)
86.86% Gujarati
COMPUTER EXPOSURE :

- Basic computer knowledge (MS office, Internet surfing).
- Handy with ORION (software)

I hereby declare that all the information furnished above is true to the best of my knowledge and belief.