Biocon Biologics Microbiology Jobs, Biotech Apply Online
DP Compliance
Location: Bengaluru, Karnataka, India
About the Job
About the Company:
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It leverages cutting-edge science, innovative tech platforms, and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes.
The company has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like the United States, EU, Australia, Canada, and Japan. With a team of ~4,800 people, Biocon Biologics is committed to transforming healthcare and lives by enabling affordable access for millions of patients worldwide.
Requirement:
Education: MSc Microbiology, Biotechnology
Key Skills: Microbiology Investigation, Aseptic Area
Experience: 4-6 Years
Primary Responsibilities:
- Physical/CCTV monitoring and review of aseptic practices during batch manufacturing, including Filling machine assembling/filling activity, Handling aseptic interventions, Lyophilizer loading., Handling product contact container & closures, Environmental monitoring and cleaning of filling machines.
- Monitoring of aseptic area cleaning by operators.
- Monitoring and reviewing critical parameters of sterile product processes.
- Participating in regulatory audits and ensuring audit compliance.
- Verifying aseptic area activity logbooks and entry/exit compliance.
- Identifying gaps as per current regulatory requirements and supporting the implementation of corrective actions.
- Training aseptic operators in aseptic practices, aseptic behavior, and good documentation practices on a continuous basis.
- Performing investigations for deviations related to aseptic area practices/handling procedures and closing deviations within timelines.
- Preparing and reviewing SOPs pertaining to aseptic areas.
- Regularly updating manufacturing operators on the latest changes in regulatory requirements.
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