Clinical Auditor Mumbai : Quintiles

[muthukalee]

Clinical Auditor

Job Description
Sr QA Auditor - Clinical-1104041

Description
Global responsibility for managing the delivery of GCP QA services for the Therapeutic Delivery Units as directed by the Global Therapeutic QA Leads. Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

RESPONSIBILITIES
* Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions. Audits may include but are not limited to: investigator site audits, process audits, office audits and telephone audits.
* Conduct Quality Planning Team meetings and review and approve resulting risk mitigation plans for projects
* Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
* Write audit plans and assure proper entry of required audits into QA systems
* Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
* Prepare, review and approve corrective action plans
* Present educational programs and provide guidance to operational staff on compliance procedures.
* Facilitate preparation for customer audits and host customer audits as delegated by the Global QA Lead
* Assist in hosting mock regulatory inspections and regulatory inspections of Quintiles facilities by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.
* Assist the Global QA Leads in management of Quality Issues
* Assist in training of new Quality Assurance staff.

Qualifications

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
* Knowledge of word-processing, spreadsheet, and database applications.
* Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
* Knowledge of quality assurance processes and procedures.
* Strong interpersonal skills.
* Excellent problem solving, risk analysis and negotiation skills.
* Strong training capabilities.
* Effective organization, communication, and team orientation skills.
* Ability to initiate assigned tasks and to work independently.
* Ability to manage multiple projects.
* Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Bachelor's/primary degree
* 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GCP experience; or equivalent

PHYSICAL REQUIREMENTS
* Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time
* Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech
* Travel required, may include international travel.

Primary Location : IND-Maharashtra-Mumbai
Other Locations : IND-Karnataka-Bangalore
Organization : IND02 - India - CDS/Product Devel

Contact us:
Quintiles
301-A-1, Leela Business Park
M.V.Road, Andheri (East)
Mumbai - 400 059
India

http://www.quintiles.com/
https://quintiles.taleo.net/careerse.../jobdetail.ftl

[Guest]

Vaishali Chaudhary
Email ID :Vaishalichaudhary_89 AT yahoo.com
CAREER OBJECTIVE :
Intend to build a career in leading Clinical Research Organization with committed & dedicated people and excellent growth to prove my skills and abilities, which will be helpful in exploring and widening the horizon of my knowledge and to contribute my hard work to the organization for achieving the common goals.
AREA OF INTEREST :
Clinical Operations, Pharmacovigillance
EDUCATION :
- Masters in clinical research management from “Institute of clinical research India” Ahmedabad.(2009-11)
- Post Graduate Diploma in Pharma Business Management from “Institute of Clinical Research India” Ahmedabad secured First class.
- Bachelor of Science with specialization in Microbiology from V.P. & R.P.T.P Science College, Vallabh Vidhyanagar secured Second class (2006-2009).
- Higher secondary school certificate from Gujarat secondary and higher secondary education board secured First class (2006).
- Secondary school certificate from Gujarat secondary and higher secondary education board secured Distinction (2004).
CLINICAL RESEARCH EXPERIENCE :
- Worked as a Trainee Clinical Research Coordinator at HCG-Medi Surge Hospital, Ahmedabad since September 2010 to November 2010.
SKILL SETS :
- Flexible and adaptable with various work conditions
- Able to work under pressure efficiently
- Making good co-ordination with colleagues
- Interest in learning new things
CONFERENCE ATTENDED :
International Conference on “Trends and Opportunities in clinical trials” –Mumbai 19th and 20th November 2010.

PROJECT UNDERTAKEN :
1) Title : To evaluate anxiety and depression levels with response to chemotherapy and radiation in breast cancer patient.
Submitted To : Institute of Clinical Research, Ahemdabad (Prist University)
2) Title : Inflation Rate and Common Man
Submitted To : Institute of Clinical Research, Ahemdabad
3) Title : Information System Used in clinical Trial
Submitted To : Institute of Clinical Research, Ahemdabad
SEMINAR/ PRESENTATION GIVEN :
- Presentation given on “Principle of Good Clinical Practice” as a study assignment at Institute of Clinical Research India, Ahmedabad.
- Designed CRF on Dyslipidemia as a study assignment at Institute of Clinical research India, Ahmedabad.
INTEREST :
- Travelling, Listening music , Playing bad-Minton
LANGUAGE KNOWN :
- Read, write and understand English, Hindi and Gujarati
COMPUTER SKILLS :
- Well versed with MS Office Suite and Internet applications.

[Guest]

RESUME

SANTHOSH PAWAR.V
E–Mail : santhosh.pawar1 AT gmail.com


CAREER OBJECTIVE :
To obtain a promising position in an organization, where I use my skills and contribute myself in the growth of the organization.
ACADEMIC PROFILE :
COURSE INSTITUTE BOARD/UNIVERSITY YEAR OF PASSING AGGREGATE (%)
B.pharmacy
SPICR.Vikarabad
Dist-Rangareddy JNTU University 2011 65.00
Intermediate Swarna Bharathi jr. college, Hakeem pet,
Mahabunager Board of Intermediate
Education, A.P 2006 67.40
S.S.C ZPHS,
Mohammadabad.
Dist-Rangareddy Board of Secondary
Education, A.P 2004 73.30
PROJECT WORK DETAILS :
B. PHARMACY – Method Development and Validation Parameters of Risperidon by Using Rp-Hplc Method
Project Description : RISPERIDON mainly used in the treatment of Psychosis. The analyte was resolved by using a mobile phase Acetonitril and potassium Dihydrogen phosphate in the ratio of 80:20 (v/v) at a flow rate of 0.7 ml/min an isocratic HPLC system consisting of shemadzu prominence HPLC pump UV visible detector ,a C18 column thermo(250 × 4.6mm) at a wavelength of 254nm. The linear dynamic range for risperidone was 20-100mcg/ml respectively. Recovery study carried out by standard addition method (CHANDRA LABS).
PROFESSIONAL ACTIVITIES :
- Undergone Industrial training on instruments, Dissolution Apparatus, Disintegration apparatus, tablet punching machine, HPLC.
EXTRA CURRICULAR ACTIVITIES :
- HPLC : worked three months for B pharm project work on Resperidone drug method development and validation.
- I presented a poster during 2010 Indian pharmaceutical congress (IPC) Analysis department (Method development and validation parameters of Resperidone)
- Participated and won prizes in sports, education and painting competitions at school and college level.
COMPUTER SKILLS :
- Application / Package : MS Word, MS Excel and MS Power Point.
- Browsing : Internet.
AREA OF INTEREST :
- Formulation Research and development
- Formulations