www.ipcalabs.com Ipca Laboratories Ltd Mumbai : Regulatory Affairs Executive

[muthukalee]

ipcalabs.com

Regulatory Affairs Executive

Company : Ipca Laboratories Limited

Location : Ipca Mumbai

Division : Head Office Department

Designation : EXE.-REG.AFFAIRS

Job title Executive - Regulatory Affairs

No. of Positions : Multiple

Position Type : Full Time

Job Responsibilities : Will be responsible for ANDA filings in US & Formulating the regulatory policies & SOP's

Job Specifications :
Age Group : 25 to 30 Year(s)

Educational Qualifications : M PHARM

Experience (years) : 4 Year(s)

Experience(Job Related) :
Less than 5 Years
2 Years as Officer
2 Year(s) in the same function
2 Year(s) in the same industry

Experience Area : Experience in CTD

apply at hrd@ipca.co.in / hrdtech@ipca.co.in

About us :
Ipca is a fully integrated, rapidly growing Indian pharmaceutical company with a strong thrust on exports. Ipca's APIs and Formulations produced at worldclass manufacturing facilities are approved by leading drug regulatory authorities including the US-Food and Drug Administration (FDA), UK-Medicines and Healthcare products Regulatory Agency (MHRA), South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health Vigilance Agency (ANVISA) and Australia-Therapeutic Goods Administration (TGA). With operations in over 100 countries, exports account for over 52% of the company's income.

Contact ud :
Ipca Laboratories Limited
142 AB, Kandivli Co-operative
Industrial Estate Ltd.,
Kandivli (West),
Mumbai - 400 067. Maharashtra.
http://www.ipcalabs.com/

[Guest-IJT]

nehal kulawade
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The submitted value of field named "Email :" is:
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nehalkulawade AT yahoo.com
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The submitted value of field named "Designation / Name of the Post / Skill Set" is :
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regulatory affair, qualityassurance,quality control
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The submitted value of field named "Copy Paste Your CV / Resume Here :" is:
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RESUME
Name of the applicant : Nehal S Kulawade
E-mail : nehalkulawade AT yahoo.com
College : Modern College of Pharmacy (for Ladies),Moshi,
Pune.
Career Objective : To obtain a position with an organization which can utilize my
Qualification, abilities and experience leading to mutual growth
- Seeking a position to utilize my skills and abilities in the Pharmaceutical Industry that offer professional growth while being innovative, resourceful and flexible.
- To associate myself with an organization in which I can work to my highest potential and make significant contribution towards growth.
EXAM UNIVERSITY YEAR OF PASSING % MARKS
B.PHARM(FINAL) PUNE 2008-2009 65%
T.Y.B. PHARM PUNE 2007-2008 62%
S.Y.B.PHARM PUNE 2006-2007 55%
F.Y.B.PHARM PUNE 2005-2006 55%
H.S.C MUMBAI 2004 56%
S.S.C MUMBAI 2002 63%
- Has appeared in the SENIOR LEVEL NATIONAL LEVEL PHARMACY TALENT SEARCH EXAMINATION.
- Attended 60th INDIAN PHARMACEUTICAL CONGRESS 2008 DWARKA, NEW DELHI.
- Also visited various industries such as SERUM &AGIO to increase knowledge as part of syllabus.
- Also worked as sales girl in welcome chemist.
Computer Has appeared for MS-CIT exam in year April2006 and secured 86
Knowledge : marks and also have some basic internet knowledge.
Work skill : Experience in handling instrument like Compression Machine, D&B
Tooling, Coating Systems like Conventional pan,
UVSpectrophotometer etc.
Industrial training : Industrial training at SANMOUR PHARMACEUTICAL, Thane.
Department : Research & Development.
Project work : On Simultaneous Estimation of multicomponent samples by . Spectrophotometric method and novel application of
Hydrotropic solubilisation phenomenon

Languages known : English, Marathi, Hindi.
Strengths : 1) To concentrate on work.
2) Will to Learn New Thing which is useful to
Company Progress & Myself.
Area of Interest : Quality Assurance
Regulatory affair
Production
NEHAL S KULAWADE
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4097465
Date & Time : 6th May 2011 3:20 PM (UTC)
IP Address : 180.188.238.154
Browser Info : Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.1; SV1; GTB6)
Predicted Country : --

[Guest]

CURRICULUM – VITAE
PAYAL H. PATIL M.PHARM
Email : pharmapayal AT gmail.com

OBJECTIVE :
To pursue a challenging carrier in a progressive organization that gives me scope to enhance my knowledge and skills and be a part of the team excel in work towards the growth of the organization.
EDUCATIONAL QUALIFICATION :
Qualifying Examination Institute University/ Board Year of Passing Percentage
M.pharm.
(Pharmaceutics) SES’s, R.C.Patel Institute of Pharmaceutical Education & Research , Shirpur North Maharashtra University, Jalgaon Appeared
M.pharm.
(Pharmaceutics)
1st year. SES’s, R.C.Patel Institute of Pharmaceutical Education & Research , Shirpur North Maharashtra University, Jalgaon 2010 75.70%
B. Pharm. SES’s, H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur North Maharashtra University, Jalgaon 2009 71.57%
H.S.C. SES’s, R.C.Patel Arts, Science,
commerce Junior College, Shirpur Divisional Board, Nasik 2005 79.00%
S.S.C. SES’s, R.C.Patel English Medium School, Shirpur Divisional Board, Nasik 2003 82.66%
Additional Qualification :
- Qualified GATE-2009 with 94.34 percentile score(All India Rank :1351)
- Qualified “Maharashtra Talent Search Examination” held in 2001.
- Finished certificate course “Facilitating Excellence in Effective Leadership (FEEL)”
Project Work :
- Completed M.pharm project work in Formulation & Evaluation of Bilayer Tablet.
- Completed a project in Formulation & Evaluation of Semisolids (Cream, Gel and Ointment) in association with colleauge.
MEMBERSHIPS IN PROFESSIONAL ORGANIZATIONS :
Registered Pharmacist with Maharashtra State Pharmacy Council, Mumbai.
TRAINING AND EXPERIENCE :
- Completed 1 month training at LUPIN PVT. LTD., AURANGABAD.
- Completed 6 month M.pharm project training at MJBIOPHARMA PVT. LTD., NAVI MUMBAI.
Visit at Pharmaceutical Industries :
- Lupin Pvt. Ltd., Aurangabad
- Mjbiopharma Pvt. Ltd., Navi Mumbai
- Fortune Pharma, Aurangabad
PRESENTATIONS/SEMINAR :
- Presented poster at ‘The Indian Pharmaceutical Association’, Pune in 2006
- Attended seminar held by I.P.E.R, pune on ‘Scope and Potential after Pharmacy’ in 2005.
- Attended & won 3rd Prize in Poster presentation at University of pune
sponsored three days National level conference on ‘Advances and trends in Drug Development Process’ held at MAEER’S, Maharashtra Institute of Pharmacy, Pune.
- Attended AICTE Sponsored Two Days National Seminar on “Role of Communication Skill in Pharmacy” organized on 21st & 22nd march 2011 at R.C.Patel Institute of Pharmaceutical Education & Research, Shirpur.

KEY SKILL :
Instrument Handling :
Dissolution Apparatus
Diffusion cell
UV spectrophotometer
IR spectroscopy
Tablet Machine
Viscometer (DV-E) & Viscometer (LV-E)
Zeta Sizer
Homogenizer
Spray Dryer
HPLC
COMPUTER SKILL :
- Completed Computer course from CDAC.
- Proficient in Microsoft word, Excel, Power Point, Internet operations
- Also proficient in handling PCP disso, Optimisation software.
PROFESSIONAL INTEREST :
Regulatory affairs and Quality assurance dept.
EXTRA CURRICULUM ACTIVITIES :
- Actively participated in various cultural activities like Drama, Anchoring, Elocution, Extempo, Debate, and sports activities such as Cricket, Carrom and Table tennis & Badminton at school and college level.

[Guest]

CURRICULUM VITAE
PRADEEP KUMAR
E-mails : pksoni AT rocketmail.com
OBJECTIVE
To develop my self in the most effective and efficient manner in pharmaceuticals production field over a period of time to attain the height of success with the help of my potential and education
PROFESSIONAL QUALIFICATION
Exam Passed
University/Board
Year
Marks Obtained
B.Pharma
.V.N.I. College Greater Noida affiliated to U.P. Technical University Lucknow.
2009 60%
D. Pharma Bundelkhand University Jhansi U.P. 2006 61%
WORK EXPERIENCE
- Presently working with torrent pharmaceutical limited from Aug 2010 to till date.
- I have been worked as Assistant Production Chemist in Anant Pharmaceuticals (Karnal) since June 2009 to July 2010.
JOB PROFILE
- Proper allocation of man power in granulation area.
- Create process order by using SAP.
- Preparation of sops.
- Maintain online documentation (BMR,Log Sheets,Temp & Pressure Differential Record)
- Ensuring cleaning and sanitization of core process area.
- Involve in validation and qualification activities.
INSTRUMENT HANDLING
- RMG(Tapasya)
- FBD(Alliance)
- Wrostercoater Glatte & palm glatte
- Compression MACHINE (CADMECH 45,55,75 STATION)
- Gangson Auto coater
- Capsule filling machine (AF90T)
TECHNICAL SKILL
- Good knowledge on SAP.
- Friendly with Microsoft word, excel & PowerPoint.
- Expertise in PLC based equipment.
AUDIT FACED
- ISO 2000-9000,
- GMP
- WHO
- EU
STRENGTH : -
- Sincerely Honest Hard working and self motivation

[Guest]

AZHAR AHMED SIDDIQUI
E-mail : azhar.siddiqui1403 AT gmail.com
Carrier Objectives
Seeking a position to utilize my skills and abilities in the well-established Industry that offers growth while being resourceful, innovative and flexible.
Academic Qualification
Higher Secondary : Saraswati vidya mandir school, Shajapur Madhya Pradesh Board Of Secondary Education (10+2), 2006 with 61.77%.
High School : Saraswati vidya mandir school, Shajapur Madhya Pradesh Board Of Secondary Education (10), 2004 with 74.02%.
Professional Qualification
Bachelor of Engineering in Electronics & communication engineering (2010-batch) from
Central India Institute Of Technology, Indore (Affiliated to RGPV, Bhopal) with 67.16%.
Experience Profile
I. Appointed as GET in Electrical maintenance Dept. from 1st Aug. 2010 to 31st Jan. 2011 (In Bhandari Foils and Tubes Dewas (MP).
II. Appointed as Assistant Engineer in Project Dept. in. Bhandari Foils and Tubes Siya Project Dewas (MP) from 1st Feb. 2011 to Till.
Job Profile
- Commissioning, installation, calibration and troubleshooting of power panel, control panels, Tube mills and Rolling mills.
- Work done on different type of instruments like RTD, Thermocouples, laser beam sensor for thickness of Pipe, Capacitive & Inductive proximity switches.
- Installation and erection of Transformer,CT,PT, Circuit Breakers, DP yard, Transmission line HT and LT, Pole erection, cable laying, earring, drawing.
- Cold rolling mill 4 hi and 6 hi, Tube mills for pipe dia 0.5 inch to 18 inch, Bright annealing furnace, degreasing mill, annealing pickling furnace, eddy current marking machine, HR Slitter, CR slitter, Hydraulic Press upto 150 ton to 600 ton, Cranes 2 ton to 20 ton, thruster, trouble shoot of PLC, controlling, Digital and Analogue DRIVES, plasma cutting machine, Tig and arc wielding machine.

Profession Training
SIDDARTH TUBE PVT. LTD. Shajapur (M.P.)
Cold rolling mill 4 hi and 6 hi, thickness of Sheet 0.67 inch to 0.87 inch, Bright annealing furnace, degreasing mill, annealing pickling furnace, eddy current marking machine, HR Slitter, CR slitter, Hydraulic Press upto 150 ton to 600 ton, Cranes 2 ton to 20 ton, thruster, controlling, Digital and Analogue DRIVES, plasma cutting machine, Tig and arc wielding machine.

Project Details
B.E. Course Projects (major) :
“VIDEO SURVEILLANCE Based On MATLAB”
(minor) :
“TEMPERATURE. CONTROLLER

[Guest]

RESUME
SANJEEV SHARMA

E-mail – Sharma.snjv2011 AT gmail.com
Objective
To excel in professional life through sincere and dedicated hard work and to contribute in every possible way for the betterment of the organization.
Academic Qualification
1. Pursuing B.PHARMACY from Rajasthan University of Health Science, Jaipur.
2. College : Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur.
S. No. Name of Examination Board/University Year % of marks
1. B.Pharmacy Part IV RUHS,Jaipur 2011 Awaited
2. B.Pharmacy Part III RUHS,Jaipur 2010 59.00
3. B.Pharmacy Part II RUHS,Jaipur 2009 66.00
4. B.Pharmacy Part l
RUHS,Jaipur 2008 64.00
5. Rajasthan Board (XII) RBSE,Ajmer 2004 63.00
6. Rajasthan Board (X) RBSE,Ajmer 2002 68.00
Technical Activities
- Completed One Month Training in Swiss Medicare Pvt. Ltd. Sriganganagar in Tablet and Liquid Section.
Project
- Project based on drug regulatory affairs.
Computer and Software skills
- Basic computer knowledge & Internet browsing.
- Operating system : Windows XP, Vista, Window 7.
- MS OFFICE.

Strength
- Dedication for work
- Confidence.
- Sense of responsibility
- Leadership quality
Achievements
- Diploma in Nanotechnology.
- Winner in intracollege chart competition in 2008.
- Winner in intracollege Kabbadi tournament 2010.
- Won many prizes in art and sports at school level.

[Guest]

CURRICULAM VITAE
MISS. SUSHAMA PRASHANT LOKARE
E-MAIL ID : sushma.k.9 AT gmail.com
OBJECTIVES :
To contribute to a pharmacy team as a pharmacist who serves the needs of a diverse patient population, while gradually increasing my quantifiable role over time. To work in an environment that asks for high standards of intellect, professionalism, human values and ethics. Looking for an opportunity where I can use my skills and get a high level of professional expertise.
JOB EXPERIENCE

NAME OF COMPANY : AUROCHEM PHARMACEUTICALS (I) PVT.LTD.
Kandivali (E)
NAME OF DEPARTMENT : DRUG REGULATORY AFFAIRS
DESIGNATION : REGULATORY AFFAIRS OFFICER.
DATE OF JOINING : 21ST NOVEMBER 2005 TILL CURRENT DATE
JOB DESCRIPTION
Dossier preparation :
1) Prepared CTD (Common Technical Document)
2) Prepared ACTD (Asian Common Technical Document)
3) Prepared dossiers for more than 35 countries - e.g. Semi regulated market (ROW), Latin America, South East Asia, etc. (Myanmar, Algeria, El Salvador, Cameroon, Trinidad & Tobago, Jamaica, Sri Lanka, Ecuador ,Etc.)
4) Solving Query related to submitted dossiers.
FDA Related Work :
1) Preparation of all documents required for registration of Pharmaceutical formulation.
2) Expert in preparation of documents required to issue :
- GMP Certificate
- WHO-GMP certificate
- COPP (Certificate of Pharmaceutical product)
- FSC (Free sale certificate)
- Product license
- manufacturing license
- loan license
- test license
- Non conviction certificate
- Performance Certificate
- Qualification & Capacity Certificate
- Mfg. & Marketing Certificate etc.
-
Packing material related work :
- Checking & developing text matter in artworks of cartons, foil, labels, tubes
- Preparation of patient information leaflets
- Checking & giving approval for the artwork & design of Carton, labels, foils & leaflets
- Co-ordinate with graphic artists for preparation of artwork
-
DCGI work :
- Preparation of documents required to issue NOC to export of banned drugs.
JOB DURATION : From 21st Nov 2005 to till date
CURRENT CTC : 3,80,000/-
ADDITIONAL PROFESSIONAL QUALIFICATION :
- Post Graduate Diploma in Clinico-Regulatory & Patents ( PGDCRP) from Centre for Advancement in Health Sciences, Ruia College.
- Corel Draw 14 Course
TECHNICAL QUALIFICATION
BACHALOR OF PHARMACY
SR
NO. NAME OF YEAR PERCENTAGE UNIVERSITY YEAR OF PASSING
1. FIRST YEAR 57.15% MUMBAI UNIVERSITY June 200 2
2. SECOND YEAR 58.46 % MUMBAI UNIVERSITY May 2003
3. THIRD YEAR 59.17 % MUMBAI UNIVERSITY June 2004
4. FINAL YEAR SEM (VII)
SEM(VIII) 62.00 %
57.88% MUMBAI UNIVERSITY June 2005
EDUCATIONAL QUALIFICATION
SR. NO NAME OF STD. PERCENTAGE NAME OF BOARD YEAR OF PASSING
1. S.S.C (1999) 70.26% Maharashtra board Mar-1999
2. H.S.C (2005) 60.00% Maharashtra board Feb-2001
COMPUTER KNOWLEGDE
Complete computer knowledge.
EXTRA CURRICULAR ACTIVITIES

1) Attended 3 days CphI exhibition in Dec’ 2009 (Pharmexil council) as a exhibitor for Aurochem Laboratories India Pvt.Ltd.
2) Attended one day visit to KEM HOSPITAL Mumbai
3) Attended one day visit to Associated capsules, Dahanu.
INTERNSHIP
One month training in in T. M. Thakore pharmaceuticals at Jogeshwari (W).
PERSONAL SKILLS :
- Honest and Dependable with Excellent Interpersonal skills.
- Team oriented Organized and Manage Time well.
- Flexible and Quick learner.
- Possess Leadership skills; Enthusiastic and Assertive.
- Friendly; have good Presentation skills
- I will be more interested in working for organization than for myself.
- Hard working.
-

[dipti0810]

post in Regulatory affairs Department

[Guest]

Curriculum Vitae
Binayak Sahani
E-Mail :
binayak.tulu AT gmail.com
binayak.tulu AT yahoo.co.in
Professional Experience :
Organization : SBI Life Insurance Co.Ltd.

Designation : Executive Sales Trainee(EST)
Duration : From July 2010 to Feb 2011
Objective
I look forward to associate my self with an organization, where there is ample opportunity to learn, contribute and upgrade my knowledge and skills, which can add to the growth of the organization and self.
Academic Profile
Post Graduate
2008-2010
M.B.A (Marketing & HR)
Bijupatnaik University of
Technology (BPUT), Odisha.
Graduate
2005-2008 BCA
Millenium Academy of Higher
Education, Nayagarh, Odisha.


Technical profile
- BCA from Millennium Academy of Higher education affiliated to Utkal University, Odisha.
Hobbies & Interests
- Interacting with people.
- Internet surfing.
- Photography
- Travelling
- Making friends.
- Gardening
Job Responsibility :
- To recruit team of Insurance advisors as per the corporate strategy.
- To ensure and maintain levels of productivity as prescribed.
- To focus on and develop various business segments as per the sales strategy.
- To train IAs with the help of training team.
- To uphold the brand image and ensure compliance with all internal as well as external regulations.
- Achieving unit business goals through quality recruitment and training.
Competencies
- Good team building skills, fast learner and a smart worker.
- Good knowledge of underwriting and operation process.
- Organized and well structured at work.
- Committed to deadlines and schedules.
- Honest, Sincere with a high level of
Integrity.
- Ability to take responsibilities and to achieve them.
- Training and motivation capacity.