Regulatory Affairs Mumbai : Mission Vivacare Ltd

[muthukalee]

Vacancy Position : VP-Regulatory Affairs cum QA

Candidate's Profile : P.hd candiates with 20-25 yrs of experience in Pharma Regulatory Affairs cum QA. Minimum 10years experience in Managerial position. Hardcore experience of handling QA Audits and Inspections on his own is a must. Should have well-travelled abroad with regards to profession. Age should be 50yrs and above.

Job Description and Candidate Profile :
1. Product dossier preparation in current formats like eCTD for various countries and handling their technical queries, complaints etc.
2. Participation in project teams, performing scientific and technical review on development and regulatory documentation
3. Monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay
4. Ensure adherence to schedule for maintenance of approvals, including supplements to existing approvals
5. Assess and review documentation to ensure compliance with product licences
6. Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance
7. Assign project work and review workload for all direct reports
8. Assist staff with their responsibilities establishing goals that will increase their knowledge and skills level
9. Responsible for Periodic auditing of existing facilities and controlling of the quality through integrated network
10. Responsible for Periodic quality review of the existing products
11. Overall responsible for streamlining and smooth functioning of QA for the organisation including the various locations

Department : RA & QA

Location : Mumbai

Eligible candidates may submit their resume at : hr.mumbai@missionvivacare.com

About us :
Mission Vivacare Limited is a Dynamic Health Products Company which believes that Well being is a universal right and a worldwide need as each individual can make a difference and therefore that Life…. It’s Precious.Guided by Industry experts who have been in this Business since 1947, We have established ourselves over the past 16 years as a Company making High Quality Healthcare Products – both Branded and Generic with marketing presence in over 32 countries around the world.

Contact us :
Mission Vivacare Limited
901 - A, Raheja Plaza , L. B. S. Marg,
Ghatkopar(W), Mumbai - 400086.
Tel. : +91 - 22 - 66477466
Fax. : +91 - 22 - 66477477
http://www.missionvivacare.com

[Guest]

RAHUL A. THAKUR

Email : rahulthakur50371 AT gmail.com Mobile: +91-
OBJECTIVE
To be a successful person by using full depth of my knowledge and skill; thus implementing all for the cause of growth of the company.
AREAS OF INTEREST
Data Mining, Database management, IPR, Regulatory affairs, Bioinformatics, Chemoinformatics, Computer Aided Drug Design and Software development.
ACADEMIC RESEARCH PROJECTS
Design of liver selective glucokinase activators : Pharmacophore mapping, Virtual screening and Molecular docking.
This work is on designing the glucokinase activators by structure based query generation then pharmacophore mapping. Using the pharmacophore map, screening of large databases is carried out and docking analysis of the hits retrieved.

ACADEMIC PROFILE

Qualification Year %/CGPA School/College University/board
M. S. (Pharm.)
Pharmacoinformatics To be completed in June 2011 6.23/10
(up to IInd sem.) National Institute of Pharmaceutical Education and Research NIPER, S. A. S. Nagar, Punjab
B. Pharmacy 2005-2008 62.04% Institute of Pharmaceutical Education and Research,
Wardha R. T. M. Nagpur University, Nagpur
H. S. C. 2003 59.00% U.N.H.S
Nagpur Nagpur Board, Maharashtra
S. S. C. 2001 65.06% Golden kids high school
Amravati Pune Board, Maharashtra


KEY TECHNICAL SKILLS
- Data Mining/Statistics software used : Sigmastat, Sigmaplot.
- Programing/Scripting skills : C++, Perl.
- Hardware and operating systems worked on : SGI Tezro, Windows and LINUX.
- Chem-Bio software used : Tripos Sybyl (FlexX, Unity), Accelrys Discovery Studio2.0 (Query generation), Schrodinger Maestro 9.0.21 (Glide), AutoDock4.0, PyMOL.
- Other software used : MS Access, M.S. Excel, Endnote, Visual studio 2005, Open babel, X-manager etc.
ACADEMIC ACHIEVEMENTS
- Secured All India Rank 1071 with 95.51 percentile in GATE 2009 (Pharmaceutical Sciences) conducted by IIT Roorkee.
- Secured All India Rank 215 in NIPER-JEE-2009 conducted by NIPER, Mohali.
TRAINING/WORKSHOP
- Persuing course on Clinical Data management (Oracle) and SAS programming at NIPER.
- Persuing distance learning course on, Industry Program in Pharma Regulatory Affairs (1 year) at Bioinformatics Institute of India, Noida.
- General course on IPR from WIPO, Geneva, through distance learning program, 2010.
EXTRA-CURRICULARS
- Attended “Drug Metabolism and Pharmacokinetics, Symposium 2010” at NIPER, S. A. S. Nagar, Feb, 2010.
- Attended “IPR in Biomedical Research, Symposium 2010” at PGIMER, Chandigarh.
- Participated in cricket, chess, badminton and volleyball in school and B-pharm.
PERSONAL DETAILS
- Date of birth : 25th April 1985
- Languages known : English, Hindi and Marathi.

[amale.sachin@gmail.com]

respected sir, i have 15 month experience in quality assurance in piramal healthcare .and 3 month experience in regulatory affair.