www.glochemindia.com Glochem Industries Ltd Hyderabad : Formulations Regulatory Affairs

[mskavi]

Glochem Industries Limited Hyderabad / Secunderabad : Manager – Regulatory Affairs (Formulations)
Website: http://www.glochemindia.com

Keywords: Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Mgr, US Regulatory Market, Europe Regulatory Market

Designation: Manager – Regulatory Affairs (Formulations)
Experience: 8 - 12 Years
Location: Hyderabad / Secunderabad
Compensation:
Rupees 6,00,000 - 8,00,000
Education:
UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy,M.Sc - Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 03 Jun 2009

Job Description:
-To take care of regulatory filing, DMF’s / ANDA’s
-To provide immediate response to any queries related to DMF filing / Dossiers
-To ensure a full proof submission of regulatory documents with respect to available site infrastructure

Desired Candidate Profile:
-B.Pharm / M.Pharm / M.Sc (Preferably in Organic Chemistry)
-Exposure to regulatory markets US / Europe
-Thorough & updated knowledge of all regulatory guidelines

Company Profile:
A Public Limited Company in the Business of Manufacturing & Marketing of APIs and Drug Intermediates with an Annual Turnover of about Rs.70 Crores with a significant presence in the international market.

Executive Name: Mr. Subba Rao

Address:
Glochem Industries Limited
G V Chambers, 7-2-C8 & C8/2,
I E Sanathnagar,
Hyderabad,Andhra Pradesh,INDIA 500018

Email Address: careers@glochemindia.com

Telephone: 91-0-9000888667

Keywords: Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Mgr, US Regulatory Market, Europe Regulatory Market

[Guest]

Dear sir,

I have 2.1 yrs. experience in QA, RA and successfully completed Advanced Diploma in Pharmaceutical Quality Assurance Management from IPER institute, Pune. I am looking for suitable opening for QA RA.

Thanks & Regards

Amol Barangule

Mcs-: Microbiology

ADPQAM - QA Management

amol.barangule@yahoo.com 09860957256 or 09975296802

[Guest]

i D . SUNDER NAIK completed M.pharmacy from NIPER specilization in Pharmacy practice and also completed my one year diloma course in pharma regulatory affiars under Bio informatics of india (BII). please consider my CV for suitable position in your esteemed organisation
thanking you sir
D .SUNDER NAIK
M.pharm-pharmacy-practice
NIPER-GUWAHATI

CURRICULUM-VITAE


DHARAVATH SUNDER NAIK
Mobile: +91 9703965388
+91 9618340848
E-mail: sunder.dharavath09 AT gmail.com
Sunderdharavath623 AT gmail.com
OBJECTIVE

To be professionally associated with an esteemed organization with an objective to accept the challenges in the research & development and utilize my education more meaningfully and work hard towards achieving the goals of the organization.
ACADEMIC PROFILE
Qualification Institution Board/university Year Percentage
M.PHARM(PHARMACY PRCTICE) NIPER, Guwahati NIPER, Guwahati July2010 completed 6.76 CGPA
PG Diploma in Pharma Regulatory affairs BII(Bio informatics of india) BII,Noida 2010 67.33%
B. Pharma SRR pharmaceutical sciences Kakatiya , warangal
2008 68.5%
H.S.S.C. S.N jr.college,waranagal AP Board hyderabad 2001 66%%
H.S.C. Adarsha high school, warangal AP Board hyderabad 1999 78%
OTHER QUALIFICATION
- Qualified in GATE-2008 with 83.13 percentile (AIR-4610).
- Qualified in NIPER-JEE2008(AIR -1805)
STRENGTHS
- Positive Attitude and Self confidence.
- Hardworking.
- Enthusiastic to grasp newer knowledge with latest technical skills.
- Determination towards assigned work.
PROJECT UNDERTAKEN
- Minor Project: “sop preparation and its safety in pharmaceutical industries under Bioinformatics of india”.
Major Project: “Drug-Drug interaction in medicine IPD in GMC Hospital”.
SKILLS
- Good communication skills in English.
- Computer knowledge in MS Office, SPSS,
CONFERENCS&WORKSHOPS
1. Workshop on “Scientific Paper Writing and Research Methodology” organized by IAMM& ICMR.
2.National Symposium on Pharmacovigilance organized by Gauhati Medical College and NIPER, Guwahati .
FIELDS OF INTEREST
- Regulatory Affairs.
- Pharmacovigilance
- Clinical Trail Operations.
- Preclinical studies
- Bioequivalance studies ,pharmacokinetic and pharmacodynamic studies
TRAINING
1. Industrial training in quality control department and production in the tablets section
2. Completed the examination Open access GCP test from PharmaXM.( score 21/25: 84%)
PERSONAL DETAILS
Name : DHARAVATH SUNDER NAIK
Father’s Name : Mr. DHARAVATH NARAYANA
Mother’s Name : Mrs. DHARAVATH LAXMI
Date of birth : 01Stfebt. 1984
Language proficiency : English, Hindi, Telugu
Marital status : Single
Permanent address : Hno 1-9-405, Julywada, Subedari, Hanamkonda, dist: Warangal
Andhrapradesh. PIN: 506001

Telephone No. : 09703965388, 09618340848
DECLARATION
I here by declare that the information furnished above is true to the best of my knowledge.
Date: Yours faithfully
Place:
(D. SUNDER NAIK)

[Guest]

SUDHAKAR THOTA
E-mail : sudhakar.jpt AT gmail.com
Career objective :
To be in an accelerating amenable and growth oriented position in the development of quality compounds in the field of chemistry with a progressive organization. Where I would best use theoretical and technical ken in a pragmatic nature and use my analytical and inter personal traits far to the gratification of my superior and authority.
Work Experience :
1 Having 4.2 years of work experience in Pharmaceutical Industry
2 Working as a Jr.Executive in QA at Auctus pharma Limited, Hyderabad from December 2009- till date
3 Worked as Officer in QA at Aptuit Laurus, Visakhapatnam from December 2007 – October 2009
4 Worked as a Trainee Chemist in Production at Matrix Laboratories, Hyderabad from September 2006 to April 2007
5 Project in Dissolution and Disintegration of Tablets In Dr Reddy’s Laboratories, Bachupally, Hyderabad
Technical Skills :
1 Preparation and review of MPCR of finished products and intermediates.
2 Preparation and review of SOPs. Follow-up for review and revision of SOPs of all departments.
3 Documentation and data control.
4 Checking of batch records of finished products and intermediates.
5 Batch distribution and final checking of packed finished product before dispatch.
6 Plant GMP audit to check cleanliness and ongoing records.
7 Cleaning validation and process validation studies.
8 Investigation of out of specification results and rejections.
9 Investigation of market complaints.
10 Training of employees on GMP.
11 Follow-up action on audit reports.
12 Maintenance of master records.
13 Vendor audit and approval.
Computer skills :
- MS-Office (Excel, Word, Power Point)
Achievements :
1 Got Prizes in school and college level in Sports
2 Cricket captain for Nagarjuna University and Periyar University
Educational Qualification :
- M.Sc (General Chemistry) from MCAS PG College, Periyar University
- B.Sc. (M.P.C) from S.G.S Govt. Degree College, Nagarjuna University
- Intermediate from Sreevidya Junior College, Gudivada
- S.S.C. from The St.Francies High School, Machilipatnam

[Guest]

RESUME
Kannidi Sony
M.Sc Analytical Chemistry
Email : sonykannidi AT yahoo.in
Objective : Seeking a challenging and responsible research and development position where my expertise in liquid chromatography and other analytical techniques and quality assurance will be utilized.
Qualification Summary :
- More than 2 years of experience in manufacturing support laboratory.
- Performed test method transfers.
- Familiar with compliance requirements within cGMP, safety and regulatory environments.
- Operational knowledge of analytical instrumentation like HPLC, UV-VIS equipment, and data stations required.
- Extensive knowledge of and experience in drug development and working in accordance with GLP and GMP requirements.
- Other responsibilities include : analyzing samples from various sources to provide information on compounds or quantities of compounds present; using analytical techniques and instrumentation.
- Interpreting data and adhering to strict guidelines on documentation when recording data; reporting scientific results.
- Outstanding written and verbal communication.
Work Experience :
Research Chemist, Gland Pharma Limited, Dundigal
- September 2008 to present
- Responsibilities include : Implementation of calibration procedures, SOP's, working instructions of all Operational machines as well as QA/QC. Lab. Equipments as per regulated market guidelines.
- Reviewing the calibration data, IQ/OQ/PQ Documents of all the instruments and structural confirmation reports of the impurities.
- Conducting training classes at all levels. Coordinate for the all Quality activities of QA like planning, IPQA, Handling complaints, and their change control to avoid future occurrence.
- Establishment of Quality Assurance facility and procurement of inspection for new infrastructure.
- Performing analytical chemistry assays based on new and existing methodologies, operating analytical instrumentation such as HPLC, U-V, IR, and Titrator.
- Developing, establishing, and validating analytical testing methodology used to control raw materials, production intermediates, and final products, writing technical reports to document analytical methods and transferring documented analytical methods to the QC department.

[Guest]

CURRICULUM VITAE
Name : K.DEEPTHY
Email id :deepthyk09 AT gmail.com
Career Objective
To make myself recognized in whatever field I am and execute an outstanding role to attain the goals of the organization, where I can have maximum usage of my abilities which helps me to grow as well.

Academic Details
Qualification Institution Board / University Year of passing Aggregate %
(M.Pharmacy) Sri Padmavati Mahila Vishva Vidyalayam, Tirupati,A.P. SPMVV, Tirupati,A.P 2011 71
B. pharmacy Raghavendra institute of pharmaceutical education and research, Anantapur , A.P JNTU
Anantapur. 2009 78.93
Intermediate Narayana Junior College,Kurnool. Board of Intermediate Education, A.P. 2005 90.0
S.S.C Kendriya vidyalaya,
kurnool. Central board of secondary education. 2003 86.8
Technical Skills
PROGRAMING LANGUAGES :Basics in ‘C’
PACKAGES : MS OFFICE.
TRAINING & PROJECT WORK :
1. Undergone Industrial Training in HETERO DRUGS LTD., Hyderabad (Andhra Pradesh) over duration of 30 Days and learnt about basic instrumentation in Quality control, production skills, quality assurance in both bulk drugs and formulation department.
2. PROJECT (B.Pharmacy) : Design and Evaluation of Quetiapine Fumerate controlled release tablets in a duration of: 90 Days. Prepared tablets of anti-psychotic quetiapine fumerate were prepared using stearic acid, starch, guar gum as variable excipients, In- vitro dissolution studies were carried out for 24 hours and the best formulation was found through suitable statistical techniques. The formulation was found useful.
3. Project (M.Pharmacy) : Analysis Of Particle Size Distribution Of Some Pharmaceutical Powders And Dosage Forms By Skewness And Kurtosis. Prepared various dosage forms (microspheres, niosomes, solid dispersions and polymorphs) altering process parameters and then particle size, IQCS and ß2 were analyzed. In-vitro dissolution studies were performed. Both these results were compared. Respective conclusions were suggested.
ACHIEVEMENTS
1. Qualified GATE 2009
2. Poster Presentation On formulation and evaluation of Quetiapine Fumerate sustained release tablet in Gitam Pharma fest conventus’09, Vishakhapatnam, A.P.
3. Poster Presentation on the topic intellectual property rights at ATPICON 2O1O, Hyderabad.
4. Poster presentation in one day national conference on emerging trends and career opportunities in pharmacy held on 28th march 2011 in Seven Hills College Of Pharmacy, Tirupati, A.P on the topic analysis of particle size distribution of some pharmaceutical powders by skewness and kurtosis.

[Guest]

CURRICULUM VITAE
J. SHYAM,
Email : jangamshyam AT gmail.com
_____________________________________________________________
OBJECTIVE :
To work in a professionally managed Organization, which will offer continuous learning, challenges and responsible position I am looking forward to an opportunity where I can utilize my skills in constituting effectively to the success of the organization and further improvement of my personal skills.
Educational Qualification :
1 M.Sc. under Kakatiya University, Warangal from 2004 -2006.
2 B.Sc (Microbiology, Zoology, Chemistry) in Kakatiya University, Warangal in April 2004.
COMPANY PROFILE :
- MAYUKA LABS is a fast track integrated pharmaceutical company at Hyderabad, India. Having multi product manufacturing facility for API .
Carreer profile :
I have a total experience of 4 year and 9 months from Mar-07’ till to date as a QC-Chemist.
- Present working as a Executive- QC since Sep - 2009in a MAYUKA LABS Ltd., here at Hyderabad.
- I was worked 2 years 6 months in VIVIMED LABS LTD, Bidar as a Q.C Chemist.
JOB PREFERENCE :
Quality Control
WORK PROFILE :
I have worked in the following areas and developed a lot by experiencing to the Best of my knowledge
Analytical Instruments Handled :
High Pressure Liquid Chromotography
1 Waters Alliancesystem(PDA Detector)with Empower2 software
2 Waters system(Uv Detector)with Empower2 software
3 Younglin manual system(Uv Detector)with Autochrom-2000 software
Gas Chromotography :
1 Chemito GC-1000(FIDDetector) with chimito chrom-2000 and Iris32 software
2 Nucon GC system(FIDDetector) with Autochrom-2000 software
3 K.F.Titrator & M.R.Apparatus handling.
4 Calibration of all mentioned above instruments.
As a Chemist :
1 Maintenance and calibration of Analytical Instruments.
2 Having good experience in analysis of Raw materials, inprocess samples in finished products.
3 To maintain instrument calibration sheets and control samples.
4 Preparation and follow up of analytical reports of Raw materials in process
samples finished products.
DOCUMENTATION ACTIVITIES includes :
- Preparation of SOP’s .
- Document Compliance as per the quality systems and guidelines.
EXTRA CURRICULAR SKILLS :
- Able to access computer through MS Office and net browsing.
STRENGTHS :
1 Ability to learn new concepts quickly
2 Team Player
3 Good Analytical and Technical Skills