Biocon, India's largest biotech company is focused on delivering affordable innovation. It is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune diseases by leveraging India's cost advantage to deliver affordable healthcare solutions to patients, partners and healthcare systems across the globe.
Requirement: Senior Executive - HC/JC/2493/2013
Job Category: Medical/Healthcare/Bio-Tech
Location: Bangalore
Experience: 4.00 to 8.00 years
Education: M.Pharm, M.Sc Skills
ICH-GCP and other guidelines and regulations applicable for the conduct of Clinical Trials
OECD principles of GLP, USFDA 21 CFR Part 58 and other guidelines and regulations applicable for the conduct of Nonclinical Trials
Bioanalytical guidance(s) for example, US FDA and EMA guidance
World Health Organization – Good Clinical Laboratory Practice.
Use of Computer applications especially MS Office
Communication and presentation skills.
Job Description
Quality Assurance related to Clinical Studies-
Responsible for maintenance of Quality System related to GCP, as applicable, for studies sponsored by Biocon.
Maintain a Quality System for the conduct of Clinical Studies
Review procedures as and when required.
Implement Standard Operating Procedures
Perform audits of Clinical CRO(s)
Perform audits of Trial sites
Report Audit findings as required
Audit vendors contributing to Clinical Trials
Review document(s) / records(s) (not limited to the following) –
Standard Operating Procedures as applicable
Investigators Brochure
Clinical Trial Protocol
Subject Information sheet and Informed consent documents
Trial Master Files and Site Master Files
Source Data
Quality Assurance related to Nonclinical Studies-
Responsible for maintenance of Quality System related to GLP, as applicable, for studies sponsored by Biocon.
Prepare and Review procedures as and when required
Implement Standard Operating Procedures
Performing audits of Nonclinical CRO(s)
Perform Audits of Study phases at the Nonclinical CRO(s)
Report Audit findings as required—
Review document(s) / records(s) (not limited to the following) -
Standard Operating Procedures as applicable
Study plans
Study reports
Study related raw data
Quality Assurance related to Bioanalytical Studies-
Responsible for maintenance of Quality System related to GLP and GCLP, as applicable, for studies sponsored by Biocon.
Training of personnel on principles of GLP and GCLP in the Bioanalytical Group.
Perform audits of the Bioanalytical laboratory and other laboratories performing work in support of Nonclinical and clinical Studies
Report Audit findings as required.
Maintaining records of audits / inspection
Control of Non-conformities and Corrective Actions
Review document(s) / records(s) (not limited to the following) -
Standard Operating Procedures as applicable
Method validation protocols and reports
