EXECUTIVE

• Ensuring effective implementation of EHS management system in the organization. To follow the established procedures and policies of the company pertaining to EHS and report on the performance to the management.
• Ensuring safety measures are available and followed during execution of all activities
• Adherence to CGLP (current Good Laboratory Practice) and cGMP (Current Good Manufacturing Practices).
• Adherence to Good documentation practices.
• Responsible for maintaining documents in Microbiology department.
• Verification of annexures for its completeness and correctness after completion of activity.
• Maintenance of Media plates and sterile swab stock records.
• Verification and maintaining the plates and annexures inside the area's as per requirements for smooth environmental monitoring activity function without any interruption.
• Timely escalation and communication to the leads for any delay in activities and any challenges faced while performing the activities
• To execute any other work allocated as per the requirements
• Good documentation practices.
• Environmental monitoring for the areaM1, M2, INNOCULUM, QC, W20 and document the same.
• Utility monitoring (Water) and Environmental monitoring trend analysis for M1, M2, INNOCULUM, QC, W20.
• Co-ordinating results to production.
• Qualification and re-qualification for areas like, M1, M2, Inoculum, QC, W20.
• Assessing production, QA, external vendors, auditors, and other personnel for gowning qualification/re-qualification and documenting the same.
• Planning and execution of environmental monitoring program in production area.
• Aseptic process simulation.
• Temperature /pressure monitoring of Instruments and quality control microbiology.
• Sample management and sample segregation and related analysis.
• Initiation and Investigation of out of specification/out of trend results, change control, deviations, and incidents.
• Audits- Facing audits and compliance to the observations.
• Timely updating of ongoing training records and maintaining the same.
• Performing the routine analysis and updating the results in NOVA EM/Utility LIMS, LABWARE
• Giving filling line clearance for formulation, Vial, cartridge, Syringe filling and filtration areas.
• Responsible for cleaning and maintenance activities of incubators of the microbiology.

• Ensuring effective implementation of EHS management system in the organization. To follow the established procedures and policies of the company pertaining to EHS and report on the performance to the management.
• Ensuring safety measures are available and followed during execution of all activities
• Adherence to CGLP (current Good Laboratory Practice) and cGMP (Current Good Manufacturing Practices).
• Adherence to Good documentation practices.
• Responsible for maintaining documents in Microbiology department.
• Verification of annexures for its completeness and correctness after completion of activity.
• Maintenance of Media plates and sterile swab stock records.
• Verification and maintaining the plates and annexures inside the area's as per requirements for smooth environmental monitoring activity function without any interruption.
• Timely escalation and communication to the leads for any delay in activities and any challenges faced while performing the activities
• To execute any other work allocated as per the requirements
• Good documentation practices.
• Environmental monitoring for the areaM1, M2, INNOCULUM, QC, W20 and document the same.
• Utility monitoring (Water) and Environmental monitoring trend analysis for M1, M2, INNOCULUM, QC, W20.
• Co-ordinating results to production.
• Qualification and re-qualification for areas like, M1, M2, Inoculum, QC, W20.
• Assessing production, QA, external vendors, auditors, and other personnel for gowning qualification/re-qualification and documenting the same.
• Planning and execution of environmental monitoring program in production area.
• Aseptic process simulation.
• Temperature /pressure monitoring of Instruments and quality control microbiology.
• Sample management and sample segregation and related analysis.
• Initiation and Investigation of out of specification/out of trend results, change control, deviations, and incidents.
• Audits- Facing audits and compliance to the observations.
• Timely updating of ongoing training records and maintaining the same.
• Performing the routine analysis and updating the results in NOVA EM/Utility LIMS, LABWARE
• Giving filling line clearance for formulation, Vial, cartridge, Syringe filling and filtration areas.
• Responsible for cleaning and maintenance activities of incubators of the microbiology.

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