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Senior Executive -quality Assurance @ Biocon Ltd.

By: JobSearch | Views: 1886 | Date: 17-Mar-2013

Senior Executive -quality Assurance @ Biocon Ltd.Education UG - B.Pharma PG - M.Pharma, M.Sc - Bio-Chemistry, Chemistry DOCTORATE - Doctorate Not Required

Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world.
DesignationSenior Executive -quality Assurance
Job Description

A. Quality Assurance related to Clinical Studies--

 

1.Responsible for maintenance of Quality System related to GCP, as applicable, for studies sponsored by Biocon.

2.Maintain a Quality System for the conduct of Clinical Studies

3.Review procedures as and when required

4.Implement Standard Operating Procedures

5.Perform audits of Clinical CRO(s)

6.Perform audits of Trial sites

7.Report Audit findings as required

8.Audit vendors contributing to Clinical Trials

9.Review document(s) / records(s) (not limited to the following) -

a]Standard Operating Procedures as applicable

b]Investigators Brochure

c]Clinical Trial Protocol

d]Subject Information sheet and Informed consent documents

e]Trial Master Files and Site Master Files

f]Source Data

B.Quality Assurance related to Nonclinical Studies--

1.]Responsible for maintenance of Quality System related to GLP, as applicable, for studies sponsored by Biocon.

2]Prepare and Review procedures as and when required

3]Implement Standard Operating Procedures

4]Performing audits of Nonclinical CRO(s)

5]Perform Audits of Study phases at the Nonclinical CRO(s)

6]Report Audit findings as required

7]Review document(s) / records(s) (not limited to the following) -

a]Standard Operating Procedures as applicable

b]Study plans

c]Study reports

d]Study related raw data

C.Quality Assurance related to Bioanalytical Studies-

1.Responsible for maintenance of Quality System related to GLP and GCLP, as applicable, for studies sponsored by Biocon.

2.Training of personnel on principles of GLP and GCLP in the Bioanalytical Group

3.Perform audits of the Bioanalytical laboratory and other laboratories performing work in support of Nonclinical and clinical Studies

4.Report Audit findings as required

5.Maintaining records of audits / inspection

6.Control of Non-conformities and Corrective Actions

7.Review document(s) / records(s) (not limited to the following) -

a]Standard Operating Procedures as applicable

b]Method validation protocols and reports

c]Sample Analysis Plans and Reports

d]Study related raw data

Desired Profile1.ICH-GCP and other guidelines and regulations applicable for the conduct of Clinical Trials.

2.OECD principles of GLP, USFDA 21 CFR Part 58 and other guidelines and regulations applicable for the conduct of Nonclinical Trials.

3.Bioanalytical guidance(s) for example, US FDA and EMA guidance.

4.World Health Organization Good Clinical Laboratory Practice.

5.Use of Computer applications especially MS Office.

6.Communication and presentation skills.

Experience4 - 8 Years
Industry TypePharma / Biotech / Clinical Research
RoleClinical Research Associate/Scientist
Functional AreaMedical, Healthcare, R&D, Pharmaceuticals, Biotechnology
EducationUG - B.Pharma 
PG - M.Pharma, M.Sc - Bio-Chemistry, Chemistry 
DOCTORATE - Doctorate Not Required
LocationBengaluru/Bangalore
KeywordsClinical -QA, Bioanalytical -QA, Non Clinical -QA, Quality Assurance
ContactSaikat Sen 
Biocon Limited 
20th KM Hosur Road Electronic City 
BANGALORE,Karnataka,India 560100
Websitehttp://www.biocon.com/
Job Posted14 Mar
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