Job Description

Department DetailsRole Summary1. Provide quality oversight to upstream and downstream manufacturing activities like cell banking, inoculum preparation, 2kL production scale, chromatography operations & formulation of Drug Substance.
2. Responsible for upstream & downstream facility GMP compliance.
3. Responsible for shop floor compliance. Identify gaps in the system/execution and discuss with CFTs for resolution.
4. Review and approval of executed upstream and downstream batch manufacturing records and media/feed preparation checklists.
5. Review and approval of study protocol, change control, TTD, MFR, BMR, process validation, cleaning validation, protocols, reports, risk assessment, technical documents. Review and closure of QMS elements.
6. Review and approval of process recipes.
7. Responsible for ensuring process/facility related CAPA implementation and verification of CAPA effectiveness.
8. Preparation of Annual product quality review as per the planner.
9. Tracking and preparation of QA related documents such as quarterly report preparation of Error tracker matrix and shop floor inspection report.
10. Review and approval of production SOPs. Preparation and revision of site-specific QA SOPs.
11. Responsible for handling of SAP related activities.
12. Review of equipment, area qualification / re-qualification protocols and reportsKey Responsibilities1. Provide quality oversight to upstream and downstream manufacturing activities like cell banking, inoculum preparation, 2kL production scale, chromatography operations & formulation of Drug Substance.
2. Responsible for upstream & downstream facility GMP compliance.
3. Responsible for shop floor compliance. Identify gaps in the system/execution and discuss with CFTs for resolution.
4. Review and approval of executed upstream and downstream batch manufacturing records and media/feed preparation checklists.
5. Review and approval of study protocol, change control, TTD, MFR, BMR, process validation, cleaning validation, protocols, reports, risk assessment, technical documents. Review and closure of QMS elements.
6. Review and approval of process recipes.
7. Responsible for ensuring process/facility related CAPA implementation and verification of CAPA effectiveness.
8. Preparation of Annual product quality review as per the planner.
9. Tracking and preparation of QA related documents such as quarterly report preparation of Error tracker matrix and shop floor inspection report.
10. Review and approval of production SOPs. Preparation and revision of site-specific QA SOPs.
11. Responsible for handling of SAP related activities.
12. Review of equipment, area qualification / re-qualification protocols and reportsEducational QualificationsRequired Education Qualification: Bsc
Required Experience: 1 - 3 years

Biocon