Perform sterility and Bacterial Endotoxin Testing (BET) for raw materials and products.
Validation Activities:
Execute validation activities.
Prepare and review Microbiology-related SOPs, STPs, validation protocols, and reports.
Equipment Qualification and Calibration:
Conduct equipment qualification (IQ/OQ/PQ/RQ and PV).
Perform calibration activities related to the Microbiology department.
Change Control, Deviation, and CAPA:
Initiate and manage Change Control, Deviation, and Corrective and Preventive Actions (CAPA).
Bioburden Testing:
Perform bioburden tests for water, raw materials, and products.
Population Determination of Biological Indicators:
Conduct population determination of biological indicators.
Cell Bank Testing:
Perform cell bank testing.
Work Experience 5 to 8 year experience Education Post Graduation in Microbiology or Biotechnology Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence