www.glandpharma.com Gland Pharma Ltd Hyderabad : Regulatory Affairs

[mskavi]

Gland Pharma Ltd.

Designation: Asst. General Manager / General Manager - Regulatory Affairs
Experience: 5 - 7 Years
Location: Hyderabad / Secunderabad

Job Description
M. Pharmacy candidates who have 5 to 7 years of experience in Regulatory Affairs. A minimum two years of experience in handling ANDA's & EU Dossiers. This is a challenging opportunity at a very senior level.

Company Profile
A leading Pharmaceutical Company approved by USFDA, involved in Manufacturing and marketing of Small Volume Parenterals, Pre-filled syringes and other Pharmaceutical Products.

Email Address: kmrao@glandpharma.com
http://www.glandpharma.com

Keywords: Regulatory Affairs

[Guest]

i am having the same relavent experience can i get the opportunity with your organization...

[Guest]

Hello sir/madam,
I am pharma graduate from miyapur could i get oppurtunity to work with your irganisation.My email id is monali_garud AT yahoo.co.in

[Guest]

Jagadeesh Babu Joga D.No.33-26-13/c
Chalamala - ari st.
Kasturibai pet
Vijayawada AP
Mobile +91 9959143386
Mail id: jaga_121 AT yahoo.co.in

Objecti- e:
To work with full dedication in any organization which pro- ides an opportunity to exhibit my skills to the full extent for both organizational as well as my professional growth.

Area of interest:
Clinical Research (Associate/Auditor/Coordinator)
Pharmaco- igilence
Regulatory affairs
Clinical pharmacologist
Bioa- ailability &Bioequi- alence

Academic profile:
M.Pharm (Pharmacology) 70% Annamalai Uni- ersity
Chidambaram Tamilnadu.

B.Pharm 70% K V S R Siddhartha college of
Pharmaceutical sciences
Vijayawada
Nagarjuna Uni- ersity.

Academic project:
Project: Determination of the lipid lowering effect of Ator- astatin on diabetic patients with ele- ated lipid le- els.
Description: To bring the lipid profile to the targeted le- els in diabetic patients with ele- ated lipid le- els.
Targeted le- els: Fasting blood glucose 80-90mg/dl
Serum cholesterol 120-140mg/dl
Serum triglycerides 120-140mg/dl
LDL 70-80mg/dl
HDL 50-55mg/dl

Contribution: Literature Re- iew
Estimation of Bio-chemistry parameters
Analysis &Results

Certificates and recognitions:
- Registered pharmacist from ANDHRA PRADESH Pharmacy Council.
- Certificate in Good Clinical Practices, Siro clin pharma P- t Ltd.
- Certificate in Good Clinical Practices, Omnicare clinical research P- t Ltd.
- Open access GCP Test completion certificate on May 8th 2008 with score of 70%.
- Certificate for the completion of EDC Coordinator Training (Medidata) on Sep 30th 2008.
- Certificate for the completion of shipping biological substances, infectious substances for a diabetic study from High Q.
- Certificate for the EDC (Inform) training which in- ol- es AE reporting, ICH GCP, inform consent quiz.
- Certificate of ECG Training from Quintiles ECG ser- ices.
- Certificate of participation in Close out meeting of Omnicare Clinical Research Organization.
- Certificate of completion for the training of IVRS (IMPALA) from PFIZER.
- Certificate of completion for the training of RDC from PFIZER.

Seminars gi- en:
A seminar gi- en on herbal drug Ginseng titled as root of immortality at K V S R Siddhartha college of Pharmaceutical sciences Vijayawada.

Conferences attended:
- Attended to 23rd I P G A conference held in 2006 at Chennai.
- Attended and participated in pharmafest program held in 2006 at K V S R Siddhartha College of Pharmaceutical sciences Vijayawada.
- Attended and participated in blood donation program held in 2002&2003 at K V S R Siddhartha College of pharmaceutical sciences Vijayawada.

Additional qualifications:
- Diploma in hardware & networking technology
- Basic computer skills in operating system.

Professional experience:
Working as Clinical Research Coordinator at Mediciti Hospitals, Hyderabad, since Sept. 2007 to till date for;
- Phase II Diabetes Study
- Phase II/III Oncology Study
- Phase II Osteoporosis Study
- Phase III Diabetes Study
- De- ice Study and PMS studies

Responsibilities:
- Maintenance of GCP compliance in clinical trial
- Maintenance of Protocol Compliance
- Coordination with CRO
- Coordination with monitors for - isit and trial related acti- ities
- Coordination with EC
- Patient follow up
- Maintenance of trial related document
- Patient randomization with IVRS and IWRS
- eCRF entry
- Drug Accountability
- Preparation of site for audits

Personal Profile:
Name Jagadeesh babu joga
Date of Birth 19th Jan 1982
Marital status Unmarried
Languages known Telugu, Hindi and English
Nationality Indian

Declaration:

I here by declare that the abo- e mentioned details are true to the best of my knowledge and ability.

Place: Hyderabad
Date (JAGADEESH BABU JOGA)

[kurilmahendra]

dear sir
i have interested for this job here i am attaching my cv.
regards
mahendra
Mahendra Kuril
RESIDENCE & CORRESPONDING

115/162-163, Agarwal Farm,
Mansarovar, Jaipur – 302020
Contact : 9352433294
e-mail : mahendrakuril AT gmail.com

OBJECTIVE
To work in a challenging environment that would utilize my overall abilities, knowledge, skills in taking up responsibilities entrusted upon me by the Company and also which will help my career to grow in prosperous manner.

WORK EXPERIENCE

Ø Four Year working experience in Torrent Pharmaceutical Limited as a Medical Representative at Jaipur.
Ø Three month working experience in Piramal Healthcare Ltd. as business executive at Jaipur HQ.


ACHIEVEMENTS
North India Topper in Veloz-D, Pregalin-x
All India Topper in Gemitrol

EDUCATIONAL QUALIFICATION

Secondary Rajasthan Board, Ajmer , with 62%
Sr. Secondary Rajasthan Board, Ajmer , with 67%
B.Pharma Rajasthan University, Jaipur , with 67%
M.Pharma (Result awaited ),
Jaipur National University,
Jaipur.

TECHNICAL QUALIFICATION

Operating System : DOS, Windows’98
Application Tools : Ms-Office, Internet


INDUSTRIAL TRAINING & PROJECT
· Industrial Training done in 2003 with Rajasthan Drug & Pharmaceutical Limited at Jaipur in B.Pharma (IIIrd year)
· Project Work done on Low Molecular Weight Heparin in B.Pharma (Final year)
· Project work done on Dossier requirement for herbal product for submission in United state and European market.

PERSONAL PARTICULARS
Name : Mahendra Kuril
Father’s Name : Sh. M.P. Kuril
Date of Birth : 18/05/1981
Nationality : Indian
Sex : Male
Marital Status : Married

Date :

Place : (Mahendra Kuril)

[Guest]

RESUME
Ch. Anil Kumar, email :anilchitoori AT gmail.com
CAREER OBJECTIVE :
Seeking a challenging career with a progressive organization that will utilize my skills, abilities and education in management, product management and operations.
ACADEMIC PERFORMANCE :
Course Institution Year of passing percentage
M.Pharmacy
(Pharmaceutics) PRIST university,
Thanjavur, Tamil Nadu. 2008-2010 7.66 cgpa
B.Pharmacy Jeypore college of pharmacy,
Jeypore, Orissa. 2004-2008 7.48 cgpa
HSC Gayatri vidya parishad,
Visakhapatnam 2000-2004 56.8%
SSLC Ramakrishna public school,
Visakhapatnam 2002 74%
COMPUTER PROFICIENCY : Finished Course On M.S Office , and Can Handle Internet Effectively.
ACHIVEMENTS :
- Paper presented in IPA & APTI convocation held at Bharampur.
Topic on : TOTAL QUALITY MANAGEMENT.
- I used to be captain for cricket team in both school and college.
- In plant industrial training carried out at DR. Reddy’s lab, yanam.
AREA OF INTEREST :
- Formulation Research And Development,
- Production,
- Quality Assurance.
STRENGTH :
- Self initiative and confidence.
- Eagerness to learn new things.
- Willingness & ability to learn from superiors & subordinates.
PROJECTS :
M.PHARM PROJECT :
Project Heading :
CONTROLLED RELEASE FORMULATION & EVALUATION STUDIES ON M.U.P.S OF CLASS-1 DRUGS
Summary :
The formulation process was carried out in bottom spray FBP by solution layering technique. Metaprolol succinate is an acid labile drug. To bypass stomach, the formulation has to delay the release and give the release in proximal small intestine. This can be achieved by enteric coating.
The work was carried out to delay the release of metaprolol succinate by using 3 different combinations of polymers and their release rates are analyzed. The study includes preformulation of drug and excipients, formulation and evaluation, release kinetics and stability studies of both M.U.P.S and tablets respectively.
The inert core material was given drug coating and enteric coating.
Enteric coating was given to metaprolol succinate pellets of 3 different inert cores by 3 different combinations of polymers (Hpmc+Pvp ,Pvp+Ec ,Hpmc+Pvp+Ec). Enteric coated pellets were converted in to tablets and evaluated for various parameters.
Different kinetic models were applied to optimized formulation and observed that it follows zero order kinetics with Higuchi diffusion mechanism.
Stability studies were conducted at 400C/75% RH (accelerated stability testing) for 3 months. Assay, dissolution release profile of optimized formulation was studied.
B.PHARM PROJECT :
Project Heading :
A CONCISE REVIEW REPORT ON TUBERCULOSIS (TB).
Summary :
The objective of the study is to form a concise report on the disease TUBERCULOSIS (TB).
The work was carried out to know in detail about the disease and organism which is responsible. In addition, this project also includes statistical data of number of people getting infected by this disease in every year and the methods of treatment that have been carrying out for different kind of TB, like Latent TB, Pulmonary TB, MDRTB and EDRTB were studied.

[Guest]

To seek a challenging position in Bio-pharma & pharmafield, which best utilizes technical expertise and experience innovative abilities and an inter-personal skill to update my selves with the latest technologies widens my spectrum of knowledge.
Qualification College / University Year of passing %
M-Pharmacy (pharmaceutical chemistry) Mallareddy college of pharmacy, dhulapally, Secundrabad. 2010 70%
B-Pharmacy Bharath College of Pharmacy, Hyderabad. 2007 70%
D-Pharmacy K.D.R.Govt.Polytechnic, Wanaparthy. 2004 69%
Intermediate (BiPC) Srinivasa Junior College, Medak. 2002 72%
S.S.C. ZPHS, Bibipet, Nizamabad (Dist).
2000 74%
110th rank in E-CET 2005(FDH)
410th rank in PGCET 2008
- With M-Pharmacy., had 11 months of experience from July 2010 to till date as a “Executive-Regulatory affairs” in the Biopharmaceutical industry, I have gained the expertise and knowledge in Validation’s, compilations and submission of NDA’s & ANDA’s. Good knowledge in handling equipments, validation and its qualifications.
- Part of many customer audits which included MNCs like Merck etc.
- Part of major audits like ADOCIA, Brazil and Ghana.
- With B-Pharmacy , 45 days training in formulation Department in PHARMA AID Pharmaceuticals limited, Hyderabad.
Working as “EXECUTIVE-Regulatory Affairs” in YELURI FRMULATIONS PVT LTD., Hyd.
Duration : April 2011 to till date.
Reporting to : RA- Manager.
Previous Experience in Virchow Biotech As Executive in Regulatory Affairs department From the July 2010 to April 2011.
- Responsible for compilation and submission of NDA’s and ANDA’s filings in CTD format to US FDA.
- Preparation and compilation of ANDA’s (Module-2& Module-3) in CTD format to European countries like Brazil, Ghana, Lebnan, Ukraine and also to Lupin Pharma.
- Preparation and compilation of Dossiers to ROW countries like Philiphines, Myanmar.
- Good Knowledge in ICH guidelines and dealt with all modules mainly Module I,II,&III especially for European countries.
- Review of MFR’s, BPR’s, Raw material/Finished Product Specifications, STP’s, COA’s, Analytical / process Method Validations.
- Co-ordination with different functional departments for product submission.
- Preparation and Review of Package insert labels, container Labels and Art Works.
- Preparation of Dossiers for registration.
- Preparing CTD (Common Technical Document) and Dossiers.
- Filing and Organization of all regulatory Documents & Applications.
- Free sale Certificate Applications—DCA
- WHO GMP Applications---DCA
- Certificate of Pharmaceutical Product (CoPP) Applications—DCA
- Review of Documents.
- Planning, collection of data and preparation of dossiers in respect of :
Manufacturing License Applications—DCA.
- Operating Systems : Windows, Word perfect, Power Point, Excel and Chem-Draw, ACD Labs,c.
- Scientific data retrieval from various Internet portals like ScienceDirect, Pubmed, American Chemical Society, Scopus, and various searching tools like Crossfire Commander and SciFinder.
- Strong believer in following processes & standardizing operations by use of tools, templates &Ensuring process compliance.
- Highly Motivated, good communication skills, good grasp power with perseverance, ability to adapt to the existing work culture of the organization with hard and smart working nature and available as needed for the organization.
- A quick learner can work in rapidly changing environments.
- Can work as part of a team or independently with equal ease and sincerity
- Possess good aptitude and logical reasoning.
- Hard working, exuding confidence and possessing excellent time management skills.
- Drug Regulatory Affairs, Quality Assurance, Analytical R&D, Pharmacovigilance, Bio Analytical & Drug Discovery
Title : Synthesis and Anticancer Activity of Peptide Derivatives

[Guest]

RESUME
Mr. : Nanaji Varanasi
Email : nanaji.gist AT yahoomail.com

Career objective :-
Intend to build career with leading Pharmaceutical Industry with committed and dedicated people, which will help me to explore myself fully in pharmacy sector and realize my potential .willing to work as a key player in challenging and creative environment.
Personal strength :-
Responsible, self-directed, hard working, creative and self motivated to work independently or in team. Great zeal for promoting and maintaining the interest of company and undertaking the challenges.
Experience : Fresher
Educational qualification :
Class School/College Board/University Year of passing
10th Govt.Boy’s High School, Gunupur BSE, Odisha 2003
+2 (Science) Gunupur College, Gunupur CHSE,Odisha 2006
B.Pharmacy Gayatri Institute Of Science & Technology, Gunupur B.P.U.T ,Odisha 2010
Research project :-
B. Pharmacy : I have carried out a literature survey on “RECENT ADVANCES IN NOVEL DRUG DELIVERY SYSTEMS” under the guidance of Mr.Mahamed Riyaze Ahmed, Gayatri Institute of Science & Technology, Gunupur
Equipments handled :
1. Dissolution Apparatus
2. UV Spectrometer

[Guest]

RESUME M.V.S.SANTOSH KUMAR
Santoshnani999 AT gmail.com
Career Objective :
To stay on the cutting edge of technology advance and to apply my skills for the best of my employer and myself.
Educational Qualifications :
- M.SC Microbiology in Dr.L.Bullayya College Visakhapatnam under Andhra University in 2011 obtaining 72% (aggregate 7.68).
- B.Sc Microbiology, Biotechnology, Biochemistry in R.K Degree College Vizianagaram under Andhra University in 2009 obtaining 67%.
- Intermediate Bi.pc in Narayana Junior college Vizianagaram in 2006 obtained 65.3%.
- S.S.C in Dr.Besant English medium high school Vizianagaram in 2004 obtained 70%.
Computer Skills : MS-Office, Internet browising.
Achievements :
- Participated in national level seminar in Maharaja PG College at Vizianagaram.
- Achieved First prize in National Seminar on topic INVISTIGATION OF ANTIBIOTIC SENSITIVITY BY THE MICROORGANISMS ISOLATED FROM FOMITES.
- Participated in Swine flu camp at Dr.L.Bullayya College Visakhapatnam.
PROJECT PROFILE :
FINAL PROJECT : Title: INVESTIGATION OF ANTIBIOTIC SENSITIVITY BY THE MICROORGANISMS ISOLATED FROM FOMITES. Team size: 1
Description : This was the Project done in M.SC. This project mainly aimed on the ANTIBIOTIC SENSITIVITY BY THE MICROORGANISMS ISOLATED FROM FOMITES.

[Guest]

i am pharmacy fresher having pharmaceutics specilisation

[shivajyoti]

Jyoti Thakur
M.Sc. Final Microbiology (Pursuing)
email : dhonisfriendjyoti AT gmail.com
Objective :
To work and develop in an effective environment where my qualities would be encouraged, so as to convert my strengths and values into organizational benefits and to raise the organizations prosperity with me as a part of organization.
Qualifications :
M.Sc. Previous Microbiology (2011), BMM Sec-9, Bhilai
B.Sc. (2010), BMM Sec-9, Bhilai
H.S.S.C. (2007), S.N.G.V.B. Sec-4, Bhilai
H.S.C. (2005), S.S.S. Sec-7, Bhilai
Computer Proficiency :
Operating system - Windows 7/XP/2003
Package - MS Office
Languages - Basic of computers
Projects Undertaken :
Title- "Recombinant DNA Technology & Polymyxin", 7 days workshop, niTza Biologicals, Hyderabad.
Title- "Detection of lux gene from Vibrio harveyi and its cloning and expression in e.coli and its insilico analysis", 3months project, niTza Biologicals, Hyderabad.
Three national level seminars attended.
Presentation given on national seminar on “Climatic changes and their effects on biodiversity" and “Detection of lux gene from Vibrio harveyi and its cloning and expression in e.coli and its in silico analysis”.
Two abstract has been published.
Achievements :
School level certificates.
Languages :
Both Hindi and English language well known.