Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Senior Executive - HC/JC/2493/2013
Job Description:
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
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
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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
Skills
1.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.
Additional Information:
Experience: 4-8 Years
Location: Bangalore
Education: M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th May, 2013
Job Code: HC/JC/2493/2013
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