Biocon Limited is an Indian biopharmaceutical company based in Bangalore. The company manufactures generic active pharmaceutical ingredients that are sold in approximately 120 countries and is currently hiring for the mentioned job role.
Role:- Executive/Senior Executive- QC Molecular Biology
Experience: 2- 5 years
Education: Masters in Biotechnology, MTech
Primary responsibilities:
- Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice).
- Monitoring of laboratory environment (temperature, cleanliness, fumigation etc.) and data entry on time.
- Analysis should be carried out in adherence to product specifications.
- Receipt of samples, logging the receipt of samples, placing samples in segregated location, generation of analytical reference number.
- Follow the schedules provided for testing, Testing of materials (In process, finished products and stability) with quality and compliance and updating the testing status.
- Sample processing and aliqouting in Molecular Biology laboratory.
- Sample management: Reconciling and discarding samples after test completion and review.
- Generation and maintenance of analytical records.
- Executing Analytical method transfers and Analytical method validations.
- Review of analytical test reports test reports (In process, finished products and stability).
- Maintenance and calibration of equipment/pipettes belonging to the Molecular biology laboratory in coordination with maintenance and instrumentation department.
- Cleanliness and orderliness of the work benches, instruments, logbooks, and documents.
- Reporting malfunctions and requisitioning chemicals/reagents /inventory on time.
- Reporting gaps in procedures and reporting unsafe conditions.
- Ensuring effective implementation of EHS management system in the organization.
- Logging in QMS elements (incidents, change controls, deviations, CAPAs etc.) in Molecular Biology.
- Preparation and revision of standard operating procedures, specifications, and technical documents.
- Reserve sample storage for in process stages for different products.
- Training on documentation, methods pertaining to molecular biology laboratory and re-training as per the relevant schedule.
- Review and release of outsourced tests pertaining to viral and mycoplasma testing.
- Preparation and revision of standard operating procedures, specifications, and technical documents.
- Handling of laboratory incident investigations, change controls, CAPAs and deviation investigations from Molecular Biology
Secondary responsibilities (Wherever applicable):
- Maintenance of COA and MSDS for chemicals available in the lab.
- Co-ordinating with Material Management team for the shipment of samples or reagents.