Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes.
Vacancy details:
- Department: Senior Executive
- Qualification: MSc
- Experience:5 – 7 years
- Salary: Not Disclosed
Job Description : Greeting from Biocon Biologics Limited !!!!
Important Details :
- Location: India
- Post of date:01/06/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Role Summary
1. Establish and maintain the global quality system standards for Biologics manufacturing site.
2. To follow GDP and to ensure GDP are followed in all documents during review ,approval and closure
3. Review of Batch analytical Data for completeness of information and Data authenticity
4. Review of Audit trails of QC instruments and ensure events generated are authorised
5. Review of specifications and ODS for adequacy of information and correctness
6.Monitoring of CPV parameters from QC prospectively
7.Review of Test procedures in accordance with method validation/method transfer reports
8.Review and approval of stability protocols and reports for biological products
9. Review of trends for enivironmenting monitoring,water testing,stability testing,laboratory incidents
10.Involve in investigations of OOS, OOT,OOL,deviations,incidents and ensure the investigations are timely conducted
11. Review and approval of the user authorisation request
12. Review of Protocols,reports, method validations , method verifications,risk assessments,IRS qualifications.
13.Escalation of Quality events (Critical and Data integrity) to site QA head for further actions.
14.Review and approval of OOC report from QC department
15.Prepare Quarterly reports on review of analytical reports and present fidnings to QC & QA HOD
Key Responsibilities
1. Establish and maintain the global quality system standards for Biologics manufacturing site.
2. To follow GDP and to ensure GDP are followed in all documents during review ,approval and closure
3. Review of Batch analytical Data for completeness of information and Data authenticity
4. Review of Audit trails of QC instruments and ensure events generated are authorised
5. Review of specifications and ODS for adequacy of information and correctness
6.Monitoring of CPV parameters from QC prospectively
7.Review of Test procedures in accordance with method validation/method transfer reports
8.Review and approval of stability protocols and reports for biological products
9. Review of trends for enivironmenting monitoring,water testing,stability testing,laboratory incidents
10.Involve in investigations of OOS, OOT,OOL,deviations,incidents and ensure the investigations are timely conducted
11. Review and approval of the user authorisation request
12. Review of Protocols,reports, method validations , method verifications,risk assessments,IRS qualifications.
13.Escalation of Quality events (Critical and Data integrity) to site QA head for further actions.
14.Review and approval of OOC report from QC department
15.Prepare Quarterly reports on review of analytical reports and present fidnings to QC & QA HOD
