Zenufa Laboratories Ltd Tanzania : Regulatory Affairs, DMF

[mskavi]

Zenufa Laboratories Ltd. Tanzania : Executive Regulatory Affairs
Website: Not Mentioned

Keywords: Regulatory Affairs,DMF


Designation: Executive Regulatory Affairs
Experience: 3 - 6 Years
Location: Tanzania
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any Specialization
PG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 28 Jul

Job Description:

Candidate will be responsible for preparation and assessment of product dossiers for submission to various regulatory authorities, presenting and handling queries related to dossiers and QA/QC aspects with the local FDA and other regulatory bodies.

Desired Candidate Profile:

Candidate should have a pleasant personality and liking & capability for regulatory trouble shooting pertaining to tricky queries in regulatory submissions.

Company Profile:
A fast growing professionally managed pharmaceutical company, with a state of the art and the first absolutely modern and hygi-tech facility in Tanzania, known for its specialized formulations with definite commitment to health sector and an enviable, growing product range.

Executive Name: Rachna Arora

Address:
Not Mentioned

Telephone: 0120-4304604

Reference ID:
rachna.arora@naukri.com

Keywords: Regulatory Affairs,DMF

[Guest-IJT]

Nandre Manoj Ashokrao

Address- 70,Shivaji Nagar,
Sakri.Tal.Sakri,
Dist.Dhule.(MH).
Pin-424304.
Phone no:- (02568) 242473
Mobile no.:+91 9423917573
E-Mail- manojnandre_143@yahoo.co.in

EDUCATION
MBA
July 2005-April 2007
Specialization in Material & Production
MBA higher Second class under University of Pune.
Summers Training : GlaxoSmithkline Pharmaceutical Ltd. Ambad, Nashik.

B.Pharmacy
May 2004
M.G.V.M.S. College of Pharmacy,Panchavati Nashik, with Second class of Pune University.

H.S.C.
March1998
S.G.Patil.College Sakri. First class from Nashik Divisional Board .

S.S.C.
March 1996
New English School Sakri first class from Nashik Divisional Board.


EXTRA QUALIFICATION
Diploma in Quality Control and Quality Assurance Management from I.P.E.R.(Pune) Pvt. Ltd.

EXTRA CURICULARS
Participate in state level conference on Entrepreneurship development and marketing at Shrirampur

PROJECT
GLAXOSMITHKLINE PHARMACEUTICAL LTD.AMBAD NASHIK.
“A STUDY OF PRODUCTIVITY OF LIQUID PACKAGING PROCESS”

LANGUAGES KNOWN
English, Hindi, Marathi

PERSONAL DETAILS
Sex : Male
Date of Birth : 15th April, 1981
Status : Single

COMPUTER LITERACY
Diploma in Office Automation.

EXPRIENCE
Company : cipla (Goa)
Department : Granulation (Tablet)
Designation : Trainee
Duration : 8 Months

PLACE

DATE -

SIGNATURE

NANDRE MANOJ ASHOKRAO

[Guest]

NITIN BHARDWAJ
E-Mail : nitin1197 AT gmail.
Seeking assignments in domain of Market research with an organization of repute.
Work Experience (Since 06-July-2009)
- Presently working as Regulatory Officer in Pfizer, since 06-Sept-2010 till today.

- Worked in Regulatory Affairs Department of APCER Pharma India Limited, filled dossier for Regulated market (Europe), since 03-May-2010 to 27-Aug-2010.
- Worked as Research Associate in Promed Research Centre, Gurgaon.
Since 06-July-09 to 27-april-10.
Work Involved
- Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving of Documents.
- Prepared dossier for different dosage forms such as tablet, eye drops, feed supplements and injections.
- Involved in setting up specifications for different dosage forms.
- Involved in preparation of documents.
- Preparing, reviewing and submitting dossier for different countries (Asia-Pacific and African Countries).
- Well versed with sending Samples to various countries and documentation required
- Proficiency in communication with various country for timely and smoth registration
- Understanding and well versed with Regulatory requirements of US, ICH guideline and EMEA guideline.
- Prepared dossier as per CTD format for UK submission.
- Prepared and filled dossier for European countries.
- Involved in responding of queries asked by regulatory agencies (EMEA, Asia Pacific and African agencies).
- Involved in Documentation of Dossier.
- Preparing Dossier as per different country requirements and format.
- Responding to queries asked by Regulatory Agency.
- Renewals of dossiers as per regulatory requirement.
- Review of documents.
- Coordination with Production, Formulation and Quality Assurance departments for timely Regulatory submission.
PROJECTS AND SEMINARS
M.Pharm II year Project at Advanced Drug Delivery Research (ADDR) at R&D, Panacea Biotec Ltd., Ambala-Chandigarh highway (10 months).
Industrial training at Dabur India Limited, during B.Pharm (After II year).
Attended Indian Pharmacy Council 2008, held at Delhi.
ACADEMIC CREDENTIALS
- M. Pharm-II from Jamia Hamdard, Hamdard University, New Delhi in 2009. Secured 72 %.
- M. Pharm-I from Jamia Hamdard, Hamdard University, New Delhi in 2008. Secured 73 %.
- Qualified GATE with 96.46 percentile in 2007.
- B. Pharma. from Jamia Hamdard, Hamdard University, New Delhi in 2007. Secured 73.65 %.
- 12th from Greenway Modern School, C.B.S.E., Delhi in 2003. Secured 79.2 %.
- 10th from Nutan Vidya Mandir, C.B.S.E., Delhi in 2001. Secured 76 %.
- IT Skills : Well versed with MS Office, Internet Application etc.
Achievements
- First position in B.Pharm 1st year (SFS).
- First position in B.Pharm 2nd year (SFS).
- Second position in B.Pharm 3rd year (SFS).
- Participated in Rx Champion Trophy (Cricket Tournament) and got the winner position.

[Guest]

VIJENDRA KUMAR
Email : - vijendra_saini2000 AT yahoo.com

Objective
To join a company in which I can contribute my knowledge and skills, a company which provide me a platform to work with and learn from talented people and accept my little contribution to the growth of the company.
Professional experience Experience :- 3 year
Presently working in ARCH PHARMA LABS gurgaon
· worked in“Ahlcon Parenterals India Ltd.”Bhiwadi,
From July.2008 to till date in Quality Control as a Chemist.
COMPANY PROFILE- M/s “Ahlcon Parenterals India Ltd.”
An ISO 9001 :2000&WHO-GMP certified company engaged in
manufacturing the Ophthalmic solutions, Injections and I.V. fluids
With using the state of art FFS technology at Bhiwadi, Alwar.
M/s Ahlcon Parenterals India Ltd.” Manufactures for the top most
companies like Ranbaxy, Cipla,Dr. Reddy’s, Mankind,Wockhardt,Lupin, FDC,
Microlabs, Alkem, B/Braun, Promed Exports, Intas, Sunways, Okasa,
Entod, Pharmatak, Indoco, IPCA, Optho, Orchid, Revere Labs,
Vida Labs, Viser etc.

Professional Qualification
· M.Sc. Pharmaceutical chemistry from University, of Rajasthan Jaipur in 2008.
· B.Sc.(Chemistry, Botany and Zoology) from University, of Rajasthan jaipur in 2004.
· Senior Secondary from Board of Secondary Education,
Rajasthan in 2001.
· Secondary from Board of Secondary Education,
Rajasthan in 1999.


Technical Acquaintances
Have a fair knowledge of instruments like-
· Dry Heat Incubator.
· HPLC. Shimadzu LC-2010 Cht, SIL-HTc.
· UV Visible Spectrophotometer. Shimadzu -1700
· PH Meter.
· Potentiometer Auto-Titrator.877 Titrino plus, Metrohm
· IR Spectrophotometer. IR Affinity-1,shimadzu
· Melting Point Apparatus.MEPA+
· BOD Incubator. Laminar Air Flow Chamber, Hot Air Oven,
· Liquid Particle Counter. PAMASS
· Polar meter.Perkin Elmer, autopal
· Total Organic Carbon Analyzer .TOC-Vcsh,Shimadzu
· Bursting Strength Tester. Linux-weighing balance, etc.

Quality Analysis by some techniques · To ensure timely analysis & documentation of Chemical sample
Like FP/RM and Bulk sample with SOP & STP.
· Calibration & Preventive maintenance of equipments in Chemical lab
· Completely analysis of All water sample, Drain water.
· Sampling of Raw material & Finished material.
· Preparation & Reviewing of SOP, STP & Specification. Raw materials, Finished Products & Packing materials.
· Preparation of Volumetric Solution and reagents.
· Standardization of Volumetric solution and condition monitoring of chemicals and reagent.
· Packing material Testing and Documentation.
· Calibration of instrument like UV Spectrophotometer,IR,Total Organic carbon analyzer,PH meter, conductivity meter ,Bursting strength tester, Polar meter etc.

Computer Skills · MS-Word
· Internet
· Basic knowledge of Computer.

Credentials
· Attending seminars and workshops.

[Guest]

CURRICULUM VITAE

PUNIT KUMAR
E-mail :- punit.bahar AT gmail.com
punit_bahar AT yahoo.co.in
CAREER OBJECTIVE
To work in an environment, which shall provide me a chance to sharpen my acquired skills and contribute positively in the progress of the organization with paramount results.
EXPERIENCE
Working as a Regulatory Manager with SHAH TC OVERSEAS PVT.LTD. from 3rd February 2010 till date.
Working on C.T.D. (Common Technical Document)
- Review of DMF and PMF as per SOP and documentation of each product review as per the Check list format.
- Coordination with China Regulatory Team, internal coordination and supplier if required regarding PMF and DMF.
- Checking of CDTL Samples packaging, CoA, MOA, impurity profile and if required reference standard or/and working standard as per mentioned in DMF.
- Approval of product name as per the pharmacopeia if required information from IDR /drug today.
- Resolution of marketing technical issues related to product and general queries.
- Making updation of monthly report of self DMF/PMF and DCGI queries.
- Timely Revision of SOP and formats in bilingual.
- Correctly review of CoA and Stability data before sending for sign and stamp to supplier.
- Timely resolve of DCGI query reply.
- Timely arranging open part of DMF or any technical documents required by the customer.
- Self-training, going through the release of any new in CDSCO and science magazine.
- Making presentation on the Regulatory Affairs.
- Bookmarking
ACHIEVEMENTS DURING JOB PROFILE
List of Registered Products :-
Pot. Clavulanic acid with Amoxicillin sodium 1 :5, Pot. Clavulanic acid with Avicel 1:1, Pot. Clavulanic acid with Syloid 1:1, Fenofibrate, Ornidazole and Secnidazole so on…. etc.
SOP prepare for DMF and PMF.
Prepare the Format for label, Certificate of Analysis (COA), Batch Size, Stability data, TSE/BSE Certificate and Format of Container Closure System.
RESEARCH PROJECT COMPLETED
“Therapeutic Agents in Cosmetics : Regulatory Status and Consumer Issues.”
Research Supervisor : Dr (Mrs) Sanju Nanda, Lecturer (Sr.Scale), Maharshi Dayanand University
Duration : 1year
PROFESSIONAL QUALIFICATION
B.Pharm. - 2005, Guru Jambheshwer University, Hisar
M. Pharm. (Pharmaceutics – Drug Regulatory Affairs), 2009, Maharshi Dayanand University, Rohtak
COMPUTER PROFICIENCY
- Microsoft Office package (MS word, Excel, Power point).
- Scientific data retrieval from various Internet portals like Google scholar, Science directs, Pubmed, etc.

[Guest]

Rahul Mishra
Email : rahulmishra.8689 AT gmail.com
Work experience :
- Satguru Travel & Tourism (LLC) : Working in Satguru Travel & Tourism (LLC) as Business Development Manager Kinshasa RDC. Handling the marketing and promotion affairs for the company. Controlling the Marketing team. Total experience in this company till now is of 8 months.
Achivements : Added 12 companies and ONG’s and increased the branch sales by three time from the date of my joining.
- Market Probe : Worked in MARKET PROBE under the project of NOKIA for three months as Summer Internship Programme. Work was to do the auditing of the NOKIA branding element. Also worked for the project relating to Insurance companies.
- MPhasis : Worked as an Agent in MPhasis an hp company for three months while doing my summer internship at Market Probe Global Link Pvt. Ltd.
- Worked as an Agent in CALL KRAFT international B.P.O for eight months in Lucknow.
Summer Internship Programme (SIP) :
Company : Market Probe Global Link Pvt. Ltd.
Project title : “Use of branding element at ROP and market share of Nokia a client of MARKET PROBE at Pune.”
Description of the project in brief : This project is done to check the branding element of the Nokia branding element and also to check the market share of the Nokia. Project is done on the basis of auditing done by us. To check the correct and fair picture of uses of Nokia branding element and market share we have used the medium of mystery audit. In this type of audit we have to disguise our self as customer and visit the shops.
This work done on this project is totally based on the rest of promoter shops in Pune. Mystery audit help to get the insight of the practices done by the shopkeepers and also help to get the feedback of them regarding Nokia’s service provided to them.
Market Research Project (MRP) :
Project title : “IMPACT OF ORGANIZED RETAIL ON UNORDANIZED IN INDIA”
Description of the project : This project was to check the effect of organized retail sector on unorganized retail sector. It was a real study done by me under the dean of ICFAI University, Jharkhand, Prof. Benerjea. As we all know that a big name like wallmart is planning to come India, where 97% of retail sector is covered by unorganized sector. It is valid to do a study on the changes and effect on India retail and customer.
Educational qualification :
Course Institute University/Board Year %tage/CGPA
Masters in Business Administration (Marketing) IBS, Pune. ICFAI, university, Dehradun. 2011 6
Bachelor of commerce. Shia P.G College. Lucknow University 2008 54.55
H.S.C. Raj Kumar Academy. I.S.C 2005 50.4
S.S.C. Raj Kumar Academy. I.C.S.C 2003 68.16
Additional qualification :
- Cleared Post Graduation Diploma In Financial Management (PGDFM).
- Cleared the IATA level course from Amadeus.
Achievements :
- Played boxing with two interuniversity, one open national, three state silver and one district gold;
- National level WUSHU (Routine) player;
- Played volleyball, twice at district level volleyball championship in Lucknow;
- Got third prize for singing at inter collegiate singing competition;
- Got third prize for acting in Lucknow Mahotsav;
- Got certificate of merit and ranked among top 100 artist at Inter National Youth fest;
- Worked as volunteer for Teach India (Times of India) under VIGYAN, N.G.O, for 6 month;
- Member of Rotaract club, IBS, Pune and holding the position of Treasurer;
- Awarded as “Star Achiever” in SAP conference;
- Worked as chief coordinator in college management fest[]: “Zeal 2011”.

[Guest]

Respected Sir/Madam,
I have completed my M.Pharmacy (Quality Assurance) from Annamalai University, Chidambaram. I have 3 Month experience in Precise Chemi-Pharma LTD, Nasik, Maharashtra as a QA-Officer.I am searching job in my related fields in such reputed companies like you if you gave me an opportunity i will give my level best to improve company level and also my career too.
I am interested in R&D, R.A, Q.A.
I am interested in your firm & have enclosed my resume for your consideration.
As a team member of your organization, I can provide :
- Efficiency, reliability & accuracy.
- Ability to look at challenges as opportunity.
- Ability to develop & mingle with the work environment.
I believe both my skills & personal attributes match your requirements & I would be able to effectively contribute to the team & the organization.
I would be very happy to discuss my application with you & look forward to hear from you in near future.
Yours truly
Nandre Parikshit V.

Encl : Resume.
CURRICULUM VITAE
Mr. PARIKSHIT NANDRE VIJAYRAO
E mail : parikshitnandre123 AT rediffmail.com

CAREER OBJECTIVE :
To utilize my knowledge and potential to work in growth oriented organization and which provides ample of opportunity of continuous learning, growth and advancement. I believe in the magic of team work, and I wish to give my best to the organization for which I work.
WORK EXPERIENCE :
Company : PRECISE CHEMIPHARMA,NASIK.
Title : Officer- Quality Assurance.
Duration : working since 2nd Oct’ 2011 to still a Date
Current Cost to Company : 78 Thousand per Annum
- Shop Floor [IPQA] Management
To verify the line clearance checks in Manufacturing and Packaging.
To conduct In-Process Quality Assurance checks and Monitoring of GMP on shop floor.
- Preparation of Process validation Report.
- Review of Batch Manufacturing Records & its implementation.
PROJECT WORK :
Company : Wokhardt Limited - Aurangabad.
Title : Project Trainee.
Duration : Working since 15 Sep 2010 – 14 Apr 2011.
EDUCATIONAL QUALIFICATIONS :
Examination Institute / University Marks Obtained Year
M. Pharm
Annamalai university, college of pharmacy, chidambaram 7.75/10 2011
B. Pharm
M.G.Vs College of Pharmacy, Panchavati,Nasik. 56.50% 2008
D. pharm I.I & P.T College.Pachavati Nasik 60.90% 2005
H.S.C K.T.H.M. College, CIDCO, Nasik. 44.83% 2003
S.S.C L.V.H.Vidyalaya,
Nasik 71.46% 2001
TRAINING PERFORMED :
- During Academic Year Performed Industrial Training at “BLUE CROSS PHARMACEUTICAL LTD.” NASIK
COMPUTER SKILL :
- Operating Systems : Windows 98,2007
- Knowledge of Ms-office and familiar with the internet
DISSERTATION TITLE :-
Major Project-“Process Validation of Extended Released Tamsulosin Hydrochloride Capsule USP 0.4mg” At Wockhardt Pharmaceutical Ltd. L-1, Chikalthana, AURANGABAD.MH-431 210
Mini Project-
“Literature Review of Equipment Qualification.”
TECHNICAL SKILLS
Equipment Used :
- Dissolution Apparatus
- Disintegrations Apparatus
- Double Beam U.V.Spectroscopy
- Rapid Mixing Granulation
- FBD
AREA OF INTEREST :
- R&D, R.A, Q.A.