SYMBIOTICA Speciality Ingredients Sdn. Bhd. Malaysia : QA Regulatory organic chemistry

[mskavi]

SYMBIOTICA Speciality Ingredients Sdn. Bhd. MALAYSIA Malaysia : QA Regulatory organic chemistry

Website: http://www.symbiotica.com.my/

Designation: QA Regulatory organic chemistry

Job Description:

* Able to manage the QA and regulatory affairs dept
* Ensure that organization adheres to cGMP regulatory norms viz. USFDA/EU GMP/ICH-Q7,8,9 & 10/PICS guidelines on a day to day basis.
* Documentation such as CTD, filings in various countries, US DMF filings, CEP applications
* Method development / Analytical Validation / Stress degradation studies
* Manage a team of people
* Work together with R&D dept in finalization of technical documents
* Support QC on analytical trouble shooting inorder that analysis is robust and in line with documented methods.

Desired Candidate Profile:

* Msc or Bsc in analytical or organic chemistry with 7 - 10 yrs experience.

Executive Name: Ajoy Prabhu

Address:
SYMBIOTICA SPECIALTY INGREDIENTS SDN. BHD.
No. 25, Tingkat Dua, Jalan Kelisa Emas 1
13700 Seberang Jaya, Pulau Pinang, Malaysia
Tel : (604) 397 9799 Fax : (604) 397 3979
E-mail : symbioti@streamyx.com / symbioti@tm.net.my / agp@symbiotica.com.my

[Guest-IJT]

Name : rekha bhagat
Email : rek.bhagat AT gmail.com
Designation / Skillset : regulatory affair
REKHA RAMDAS BHAGAT

'Dear Sir or Madam'
'Please consider my enclosed application for the position of Regulatory affair, QA.
I have one year of experience as a regulatory trainee in a reputed pharma company.
Yours Truly, Faithful
( Bhagat Rekha Ramdas )

Resume :

Academic record
2011 PG Diploma in Regulatory affair, BII Institute “ Noida University ” Persuing.
May 2009 Final Year B.pharm C.U.SHAH College of pharmacy, Santacruz, (Mumbai)“
SNDT University ” with 60.66% First class.
2006 Diploma in pharmacy SAS College of pharmacy, Bhiwandi“ Mumbai University ” with
82.70 % Distinction.
March 2004 H.S.C. R.K.TALREJA College, Ulhasnagar “ Mumbai University ” with 54.00%
Second class.
2002 S.S.C NRC School, MohoneKalyan“ Mumbai University ” with 76.66 % Distinction.
Research experience/ training at academic level
Industrial training in “Piramal Healthcare”, at thane during Graduate Studies for two months . In Qc department , research & development Dept., microbiology Lab.
Presentation
Hair Analysis ( B. Pharm Project ) under guidance Dr. MilindBhitre.
Excellence in Pharma field
Received Scholarship from “RATAN TATA” for the year 2006.
Professional experience
Current job description
Organization - Flamingo pharmaceuticals Pvt Ltd, Navi Mumbai.
( M.H.R.A Approved )
Designation - Regulatory affair Trainee.
MFR review and ensuring the sourcing of material, manufacturing and testing is carried out as
per Dossier.
General document preparation including Pharmaceutical development report, Product
dispatch report, COA, Master formula record.
Handling of instrument like Fraibility apparatus, Tap density apparatus, UV
spectrophotometer, Dissolution apparatus, PH meter etc.
Familiar with various Regulatory Guidelines.
Curricular/ Extracurricular certificates and awards
A certificate of honor for district level participation in chess during school.
Interests and Hobbies
My interest includes listening music, playing indoor games, reading novels..
References
Mr. Sanjay kumar( Manager Regulatory affair Dept. Flamingo pharma, Taloja )
Intrested in Regulatory and QA
DECLARATION :
I here by declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of above-mentioned particulars.
Yours Truly, Faithful
Date :
Place : Mumbai ( BhagatRekhaRamdas )
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4379858
Date & Time : 17th Jul 2011 6:02 AM (UTC)
IP Address : 27.106.29.56
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