Job Description
Job Responsibility and key Decisions
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 of 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 the 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 as per requirements for smooth environmental monitoring activity function without any interruption.
Timely escalation and communication to 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 practice.
Environmental monitoring for the area M1, M2, INNOCULUM, QC, W20 and document the same.
Utility monitoring Water and Environmental monitoring trend analysis for M1, M2, INNOCULUM, QC, W
Coordinating results to production.
Qualification and requalification for areas like, M1, M2, Inoculum, QC, W
Assessing production, QA, external vendors, auditors, and other personnel for gowning qualificationrequalification and documenting the same.
Planning and execution of environmental monitoring programs 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 specificationout of trend results, change control, deviations, and incidents.
Audits Facing audits and compliance with the observations.
Timely updating of ongoing training records and maintaining the same.
Performing the routine analysis and updating the results in NOVA EMUtility LIMS, LABWARE
Giving filling line clearance for formulation, Vial, cartridge, Syringe filling and filtration areas.
Responsible for cleaning and maintenance activities of microbiology incubators.