Clinical Quality Specialist Delhi : Progressive Life Sciences

[muthukalee]

Clinical Quality Specialist

Provide quality support functions for our BA/BE clinic. Responsibilities include reviewing and approving SOP’s; reviewing and approving study reports; case report forms, patient consent forms and clinical study reports. Will assist with client, regulatory agency, internal, and external audits as needed.

Qualifications include BA/BS degree in scientific field and at least six years experience in a BA/BE clinic, CRO environment or Quality role. At least two years in a Quality role preferred.

Additional auditing or related experience a plus.

We offer competitive salary, a comprehensive benefits package and advancement opportunity.

About us :
Progressive Life Sciences is a Contract/Clinical Research Organization (CRO) with an operating base in India that provides cost-effective (phase II, III and IV) clinical trial management and medical consulting to pharmaceutical, biotechnology, and medical device companies world-wide. Our team brings more than 200 years of experience in clinical research. Through our thorough understanding of the clinical and regulatory issues involved in clinical trials combined with our expertise in the outsourcing model we help our clients deliver quality products on time and within budget every time.

Contact us :
Progressive Life Sciences
903, Arunachal building,
Barakhamba Road, New Delhi.

info@progressivelifesciences.com
http://www.progressivelifesciences.com

[Guest-IJT]

Name : Dhanaraj
Email : dhanaraj1903 AT gmail.com
Designation / Skillset : Q.A OFFICER IN PHARMA INDUSTRY
Application for Q.A officer post

Resume :
Objective :-
I seek to my knowledge and experience in a highly challenging and continuously growing company that can provide me ample opportunities to grow intellectually, Technically and professionally in concurrence with company goal and objective.
Academic Profile :-
- S.S.C. passed in first class from S.S.V.K, Karad (Kolhapur Board) - Mar.2001
- H.S.C. passed in second class from Y.C.C.S.K.,Karad(Kolhapur Board) - Mar.2003
- B.Pharmacy in second class from S.S.C.P. Ghogaon (Kolhapur University) Mar.2009
- A computer course MSCIT passed in first class from CDACC
Professional Experience :-
Currently working in Cipla Ltd. (Okasa), Goa, as a Quality Assurance officer from Oct.2009

Job responsibilities :-
- IPQA testing. (Liquid, Tablet and Capsule formulations)
- Handling of Change Controls and Deviations.
- Validation Batch sampling. ( Liquid ,Tablet and Capsule formulations)
- Line clearance activities.
- Daily record review.
- Review of Batch Records.
- Checking Master Batch Records.
- Dispatch of finished goods.
Observations :-
- Concurrent validation.
- Cleaning validation.
Audit faced :-
Ethiopia audit in Dec. 2009
Kenya audit in Jan. 2010
APVMA in Apr.2010
France visit Aug.2010
Company Approvals :- MHRA, USFDA

Project : -A review article on PULSATILE-FLOATING DRUG DELIVERY SYSTEM.

----------------------------------------------------------------------------------------------------------------------------------
Skill sets and strengths :-
- Able to maintain positive attitude under pressure and odd situation.
- Good interpersonal and communication skill.
- Basic computer knowledge.
----------------------------------------------------------------------------------------------------------------------------------
Declaration :-

I hereby declare that the above information furnished by me is true to my best of my
Knowledge.

PLACE- karad Mr.Sonavale Dhanaraj Bhimrao
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4168694
Date & Time : 24th May 2011 2:52 PM (UTC)
IP Address : 117.204.130.58
Browser Info : Mozilla/5.0 (Windows NT 5.1) AppleWebKit/534.24 (KHTML, like Gecko) Chrome/11.0.696.68 Safari/534.24
Predicted Country : India

[Guest]

Pallavi Vitthalrao Angule
E-mail : vpallavi AT ibab.ac.in , pallavi.khadtare AT gmail.com
Objective :
Seeking a full time position as Research Associate, in an organization where my knowledge could contribute to the organization and enrich my professional skills.
Skills & Expertise :
- Genomic and Plasmid DNA isolations, Primer designing, PCR, Southern blotting.
- Restriction digestion, ligation and transformation, Agarose Gel Electrophoresis.
- General protein estimations, SDS PAGE, Native PAGE, Western blotting, ELISA.
- Salt precipitation and chromatography techniques.
- Plant Tissue Culture, Animal Tissue Culture.
- Basic lab procedures, Record keeping, literature search and basic bioinformatics.
Project Experience :
- Done a 3 month project on “Cloning and expression of Glycolate Oxidase gene in E.coli BL21(DE3) for the production of Glyoxylic Acid”.
Main activities involved were isolation of m-RNA from Spinacia oleracea (spinach) produced cDNA by RT-PCR, restriction digestion of cloning vector using EcoRI and HindIII restriction enzymes and ligation, Transformation of cloning vector in to Host Ecoli DH5a, amplification of Glyoclate oxidase gene using PCR, transcribing glycolate oxidase gene using using pET-21b(+) expression vector, purification and enzyme activity.
- Completed Msc dissertation report entitled “Characterization of DGAT 1 gene in the Indian regional buffalo”.
- Completed one month project entitled “Effect of Sulphur on Chemical properties of Soil at Vasantdada Sugar Institute Pune.
Computer Skills :
- Adequate knowledge of MS-office, Openoffice.
- Completed basic IT course MS-CIT certification.
Educational Qualification :
- PG Diploma in Biotechniques. Oct.2010 – July.2011
Institute of Bioinformatics and Biotechnology, Result Awaited.
Bangalore.
- MSc Biotechnology June.2006 – June.2008
Swami Ramanand Teerth Marathwada University, 63.33%
Nanded, Maharashtra.

- Bsc in Zoology, Dairy science, computer science. June.2004 – June.2006
Swami Ramanand Teerth Marathwada University, 69.75%.
Nanded Maharashtra.
Achievement and extra activities :
- Qualified for GATE-2011 (Biotechnology) with 84.56 percentile.
- Presented poster entitled “Enumeration of Bacterial Pathogens in Green Leafy Vegetables” in national conference on “Emerging Trends in Biotechnology for Modern Era” at Latur.
- Attended the national conference on “Environmental pollution, Disaster Management and Mitigation” at Parbhani.