Senior Executive
by Biocon Limited in Bengaluru/Bangalore
Experience: 3 to 8 yrs. Posted on: 18 Sep
Job Description
Quality Assurance related to Bioanalytical Studies
Establish and maintain a Quality System for the conduct of Bioanalytical work in support of Nonclinical and Clinical studies
Prepare and Implement Standard Operating Procedures for review of Bioanalytical studies
Perform audits of the Bioanalytical laboratories performing work in support of Nonclinical and clinical Studies
Report Audit findings as required
Maintaining records of audits
Review and Control of Non-conformities and Corrective Actions
Review of document(s) / records(s) (not limited to the following) -
o Method validation protocols
o Method validation reports
o Sample Analysis Plans
o Sample Analysis Reports
o Study related raw data
o Procedures (as applicable)
Quality Assurance related to Clinical Studies
Maintain a Quality System for the conduct of Clinical Studies
Prepare and Review procedures as 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) -
o Procedures as applicable
o Clinical Trial Protocol
o Investigators Brochure
o Subject Information sheet and Informed consent documents
o Trial Master Files and Site Master Files
Quality Assurance related to Nonclinical Studies
Establish and maintain a Quality System for the conduct of Nonclinical Studies
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 and Control of Non-conformities and Corrective Actions
Maintaining records of audits
Response to queries and deficiencies
Review document(s) / records(s) (not limited to the following) -
o Procedures as applicable
o Study plans
o Study reports
o Study related raw data
Technical / Functional Skills
Should have thorough knowledge of the following documents -
Bioanalytical guidance(s) for example, US FDA and EMEA guidance
World Health Organization Good Clinical Laboratory Practice WHO (GCLP)/08
Applicable guidance and regulations for the use of computerized systems in regulated environments
OECD Principles on GLP guidance and position papers
Code of Federal Regulations (21 CFR Part 58) and other CFRs and guidelines and regulations applicable for the conduct of Nonclinical Trials
Schedule Y of the Drugs and Cosmetics Rules of India and other applicable schedules
Good Clinical Practice - ICH (E6); Code of Federal Regulations and other guidelines and regulations applicable for the conduct of clinical Trials
Good Clinical Practices for Clinical Research in India (CDSCO)
WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects
The ICMR - Ethical guidelines for biomedical research on human participants
Use of Computer applications especially MS Office
Communication and presentation skills
Establish and maintain a Quality System for the conduct of Bioanalytical work in support of Nonclinical and Clinical studies
Prepare and Implement Standard Operating Procedures for review of Bioanalytical studies
Perform audits of the Bioanalytical laboratories performing work in support of Nonclinical and clinical Studies
Report Audit findings as required
Maintaining records of audits
Review and Control of Non-conformities and Corrective Actions
Review of document(s) / records(s) (not limited to the following) -
o Method validation protocols
o Method validation reports
o Sample Analysis Plans
o Sample Analysis Reports
o Study related raw data
o Procedures (as applicable)
Quality Assurance related to Clinical Studies
Maintain a Quality System for the conduct of Clinical Studies
Prepare and Review procedures as 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) -
o Procedures as applicable
o Clinical Trial Protocol
o Investigators Brochure
o Subject Information sheet and Informed consent documents
o Trial Master Files and Site Master Files
Quality Assurance related to Nonclinical Studies
Establish and maintain a Quality System for the conduct of Nonclinical Studies
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 and Control of Non-conformities and Corrective Actions
Maintaining records of audits
Response to queries and deficiencies
Review document(s) / records(s) (not limited to the following) -
o Procedures as applicable
o Study plans
o Study reports
o Study related raw data
Technical / Functional Skills
Should have thorough knowledge of the following documents -
Bioanalytical guidance(s) for example, US FDA and EMEA guidance
World Health Organization Good Clinical Laboratory Practice WHO (GCLP)/08
Applicable guidance and regulations for the use of computerized systems in regulated environments
OECD Principles on GLP guidance and position papers
Code of Federal Regulations (21 CFR Part 58) and other CFRs and guidelines and regulations applicable for the conduct of Nonclinical Trials
Schedule Y of the Drugs and Cosmetics Rules of India and other applicable schedules
Good Clinical Practice - ICH (E6); Code of Federal Regulations and other guidelines and regulations applicable for the conduct of clinical Trials
Good Clinical Practices for Clinical Research in India (CDSCO)
WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects
The ICMR - Ethical guidelines for biomedical research on human participants
Use of Computer applications especially MS Office
Communication and presentation skills
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Executive
Keyskills: US FDA
Desired Candidate Profile
Education:
Please refer to the Job description above UG - Any Graduate - Any Specialization
PG - MBA/PGDM, M.Tech - Any Specialization, M.Sc - Any Specialization
Doctorate - Doctorate Not Required
PG - MBA/PGDM, M.Tech - Any Specialization, M.Sc - Any Specialization
Doctorate - Doctorate Not Required
Company Profile
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. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .
Contact Details
Recruiter Name:Sweta
Contact Company:Biocon Limited
Address: 20th KM Hosur Road Electronic City BANGALORE,Karnataka,India
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