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Executive/Senior Executive- QC Molecular Biology

4 months ago

Bengaluru, India Biocon Biologics Full time

Roles and Responsibilities

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.