www.avesthagen.com Ltd Bangalore : Regulatory Affairs

[muthukalee]

avesthagen.com

Regulatory Affairs

JOB DESCRIPTION

Job ID : AGT_Head _108

Job Title : Head Regulatory Affairs

Years Of Experience : 8

Skills : Accreditations,Knowledge of WHO guidelines,Liaison skills ,Preparation of all regulatory related documents of the company

Qualification : PhD

Country : India

City : Bangalore

Key
Build and manage a Regulatory team to effectively submit the products dossiers at various stages to the National and International regulatory authorities for approval and further development.
Responsible for getting various licenses and approvals from Govt. Bodies.
Responsible for corresponding with various approval bodies like KSPCB, BARC, MOEF etc. for approvals.
Responsible for getting various accreditations and maintenance of various accreditations / licences / certificates like ISO 14001, ISO 17025, DSIR etc.
Responsible for organization of internal audits and facing audits from various certifying and accreditation bodies.
Responsible for co-ordination during external agencies audits with respect to regulatory compliance.
Responsible for regulatory affairs unit operations including organizing / conducting various committee meetings.
Responsible for organization of training programs as per regulatory requirements.
Knowledge about Indian and International Safety norms like Occupational Health and safety management system, ISO standards and Environment Management System.
Good liaison skills with Govt. regulatory agencies particularly Pollution Control Board, MoEF, DISH officials, Ministry of Commerce and Industry (Export Inspection Council of India) etc.
Build and manage a QA and QC team that works with the various divisions including the manufacturing units to ensure all quality and controls systems are in place.
Experience in conducting Internal Audits and facing Vendor or Regulatory Body Audits.
Experience in Organization of Training Programs.
Experience in co-ordination during external agencies audits with respect to regulatory compliance.
Knowledge of WHO guidelines, EHS guidelines, and other regulatory guidelines.
Should be a team player and have good interpersonal and communication skills.
Should display good convincing and negotiating skills.
Exposure to Regulatory Documents Management (Archiving and Retrieval) and Preparing procedural manuals.
Willing to develop EHS (Environment, Health & Safety) regulatory skills.
Responsible for integration with the In-house Knowledge Management System.
Responsible for training, developing and supervising the team members.
Responsible for keeping abreast with the latest developments, new inventions, domain knowledge and technology in the field of biotechnology.
Responsible for any other work that may be assigned from time to time.

Desired
PhD with 5-8 yrs exp. Knowledge of WHO guidelines, EHS guidelines. Liaison skills with Govt. regulatory agencies particularly Pollution Control Board, MoEF, DISH officials, Ministry of Commerce and Industry. Exposure to Regulatory Documents Management

Contact us :
Avesthagen Limited
Discoverer, 9th Floor
International Technology Park
Whitefield Road, Bangalore 560066, INDIA
http://203.200.56.142/jobapp/careers_new.php
http://www.avesthagen.com/

[sush_thakur]

CURRICULUM VITAE
SUSHANT THAKUR
sush_thakur001 AT yahoo.co.in


OBJECTIVE
Continuously enhancing my capabilities through the synergy of learning and earning and bring forth the best of my potential talents and an active interest in the growth of the organization.
AREAS OF INTEREST
- Research & Development, Drug Regulatory Affairs and Pharmacovigilance
ACADEMIC PROFILE
- Passed M.Pharm (Pharmaceutics) from Department of Pharmaceutical Sciences, Lovely Professional University, Jalandhar with 8.5 CGPA.
- Qualified the course entitled as “General Aspects of Intellectual Property Rights” conducted by World Intellectual Property Organization, Geneva in November 2010.
- Passed B.Pharm from Shivalik College of pharmacy, Nangal, Punjab Technical University, Jalandhar with 67% in May 2009.
- Passed Intermediate from Punjab school education board with 65% in March 2005.
- Passed Matriculation from Punjab school education board with 80 % in March 2003.
DISSERTATION
- Preparation, characterization and pharmacological evaluation of aquasomes loaded with bromelain.
INDUSTRIAL EXPOSURE
- One Month (1st July - 31st July 2008) Industrial training at Rachil pharma, Terece (H.P) in Production.
RESEARCH PROJECTS/REVIEW
S.No Research/Review Title Supervision Poster Presentation
1. Formulation and evaluation of matrix tablet of propanolol using tamarind gum polysaccharide. Ms. Madhu Rana National Conference on Innovations in drug discovery and research at Punjabi University, Patiala on 3rd March, 2009.
2. Phases of drug development of traditional herbal drugs in India Ms. Purnima Verma National Conference on Emerging Trends in Biopharmaceuticals : Relevence to human health at Thapar University, Patiala on 11th November, 2010.
PUBLICATIONS
Research article published in INDIAN DRUGS titled “Formulation and evaluation of matrix tablet of propanolol using tamarind gum polysaccharide”
EQUIPMENT EXPOSURE

- Disintegration test apparatus
- Dissolution test apparatus (Labindia DS8000)
- Friability test apparatus
- UV spectrometer (Systronic 2202, 2203)
- IR spectrometer (Shimadzu FTIR-8400S)
- Viscometer (Brookfield DE-V viscometer)
- Rotary vacuum bath (Popular india)
- pH meter (Systronic µ pH system 361)
COMPUTER KNOWLEDGE
- Basic knowledge (MS-Word, MS-Excel,MS-Power point)
- Internet surfing and browsing.
INERESTS
- Listening music, reading, traveling, surfing net and chatting.
- Learning new things and making new friends.
STRENGTH
- Hard working, sincere and dedicated towards work and organization.
- Management skills
- Willing to relocate globally.

[Guest]

KHALEEL UR REHMAN
Department of Microbiology and Biotechnology
khaleel.arjuman AT gmail.com
Seeking a suitable position to utilize and develop my abilities to the maximum level. To synergies all my strength and resources available to work with complete perfection and professionalism. To empower my organization to celestial heights by utilizing my potential to the maximum extent
Course
University/ Board
Institution
Year
Percentage
M.Sc. Bangalore university Bangalore university, Jnanabharati campus ( result awaited) 66%
B.Sc. Sree Krishna Devaraya University Balayesu Degree College 2009 76%
- Isolation of Plasmid and genomic DNA
- DNA amplification using PCR
- Agarose Gel electrophoresis
- Isolation and biochemical characterization of bacteria
- Maintenance and preservation of bacterial and fungal cultures
- Antimicrobial assay
- MS Office
- Basics C, C++
- Internet Awareness
- PCR
- Microscopes
- Centrifuge
- Hot Air Oven
- Auto Clave
- Incubators
- UV-Vis Spectrophotometer
- Agarose Gel Electrophoresis
- Chromatographic techniques (Paper and TLC)
- Analytical Method development
- Quality Assurance
- Research and Development
- Good Communication Skills
- Excellent Problem Solving Skills
- Self Motivated and Hard Working

[Guest]

Curriculum Vitae
PURVANG PANSURIYA
s Email : purvang84 AT gmail.com
CAREER INTEREST
To excel in field of Pharmaceuticals by continual learning and implementation of new technologies, through which I can contribute substantially towards the growth of the company and extract some deep professional satisfaction as well.
SYNOPSIS
- A Postgraduate Pharmacist (M. Pharm.) in Pharmaceutical technology.
- Qualified KLE All India Entrance Test-2009 with AIR-9 for Post graduation.
EDUCATIONAL BACKGROUND
Qualification Year University/College Subjects Percentage
M. Pharma 2011 KLE University’s College of Pharmacy, Bangalore, Karnataka. Pharmaceutical Technology Dissertation submitted
B. Pharma 2008 Rajiv Gandhi University of Health Science, Bangalore, Karnataka. Pharmaceutical Science 66.80
D. Pharma 2005 Government of Karnataka Board, Bangalore. Karnataka. Pharmaceutical Science 60.80
H.S.C (12th) 2002 Gujarat Secondary Education Board, Gandhinagar, Gujarat. Science 52.60
S.S.C (10th) 1999 Gujarat Secondary Education Board, Gandhinagar, Gujarat. General 69.71
PROJECTS UNDERTAKEN
Project handled entitled as “DESIGN AND DEVELOPMENT OF ONCE A DAY ORAL OSMOTIC DRUG DELIVERY SYSTEM OF ROPINIROLE” under the guidance of Mrs. Uma. A. Patil, Assistant Professor Department of Pharmaceutical technology, During Jul. 2010 to Feb. 2011, from KLE University’s College of Pharmacy, Bangalore.
SKILLSET AQUIRED
Technical skills :
- Handling and maintenance of Pilot Plant
Equipment handled :
- UV spectrophotometer (Shimadzu, Jasco)
- Dhona weighing balance
- Shimadzu digital weighing balance
- Rimek RSB-4 Rotary Tablet Press
- Rimek Coating pan
- Digital pH meter
- USP XXIII Dissolution Tester
- Friabilator
- Thermolab scientific Humidity chamber
- Spray dryer
INDUSTRIAL TRAINING :
- Hospital : - OLD CIVIL HOSPITAL, SURAT, GUJARAT.
- Period : - 06/05/2005 to 03/09/2005
- Company : - LYKA LAB LIMITED.
- Position : - Internship in Manufacturing Department.
- Period : - 27/10/2008 to 17/12/2008
ACHIEVEMENTS AND CERTIFICATIONS :
- Participated in 1st International Conference on Drug Delivery 2010 at Coimbatore, dated January 29 & 30 2010.
- Participated in a poster presentation on “ANTHELMINTIC ACTIVITY OF JATROPA CURCAS” in pharma vision 2020, Bhopal dated April 4, 2010 and was awarded as the best poster.
- Participated and Poster presentation on “RECENT DEVELOPMENT IN VACCINE ADJUVANTS : FOR IMPROVED AND EFFECTIVE IMMUNIZATION” at the International conference at Nagpur, dated June 20, 2010.
- Participated in workshop on “COMMUNITY PHARMACY” in KLE University College of Pharmacy, Bangalore dated February 14, 2010.
- Participated in national seminar on “MORDERN ANALYTICAL TECHNIQUES USED IN DRUG ESTIMATION” in KLE University College of Pharmacy, Bangalore dated 15th May 2010.
- Participated in national conference on “MOLECULAR MEDICINE AND NANOBIOTECHNOLOGY” at the NIMHANS Convention Centre, Bangalore dated October 13 & 14, 2010.
- Participated in workshop on “DESIGN AND PRODUCTION OF CRITICAL EQUIPMENT FOR BIOPHARMACEUTICAL INDUSTRY” by BIOZEEN Dated on October 14, 2010.
- Participated in a poster presentation on “ONCE A DAILY SUSTAINED RELEASE MATRIX TABLET OF PRAMIPEXOLE” at the 62 Indian Pharmaceutical Congress 2010, Manipal, dated December 17-19, 2010.
- Participated in a poster presentation on “MONOLITHIC OSMOTIC TABLET SYSTEM FOR ROPINIROLE DELIVERY” at the 2nd International conference on drug delivery-2011, Coimbatore, dated January 21 & 22, 2011.
- Participated in a poster presentation on “FORMULATION OF OSMOTIC CONTROLLED ORAL DRUG DELIVERY SYSTEM OF ROPINIROLE” at the 3rd National on Symposium on Frontiers in Drug Discovery and Process Development-2011 held at Bharati Vidyapeeth College of Pharmacy, Kolhapur on 5th and 6th March 2011.
COMPUTER SKILL
- Proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat Professional and FileMaker.
PERSONAL SKILLS
- Diligence and tendency towards pursuits of problem till end.
- Independent work skill and very quick learner.
- Professional attitude and aptitude towards hardworking.
- Accustomed to work in a dynamic, open, must win, multicultural team environment.