Job Description
Responsible for management of Microbiology lab.
Responsible for allocation of work in Microbiology lab.
To monitor sample management system and planning of testing and release of raw material, in-process samples, validation samples, packing material and finished product from microbiology laboratory as per defined procedure.
Responsible for ensuring the testing and release of raw material, packing material and finished product as per agreed timelines.
Responsible for reviewing and approving the documents related to microbiological testing.
Responsible for managing Environmental monitoring, Utility monitoring (water/Compressed gases) program.
Inform to QC Head/Designee and Responsible for Reporting of OOS, OOT, Incident, deviation, CAPA and change control as per procedure.
Responsible for leading, investigating and closure of Microbiology Out of Specification Results and finalization of associated CAPA.
Responsible for reviewing of Standard Operating Procedures, imparting training on new/changed procedures and assuring implementation of the same in Microbiology lab.
Responsible for preparation of qualification/validation protocols, ensuring validations/qualifications are executed appropriately as per the procedures and reviewing/approving the validation/qualification reports.
Responsible for planning and management of Microbiology related activities during Aseptic Process Simulation.
Responsible for participation in activities related to Sterility Assurance of product/process.
To impart training to subordinates on aseptic techniques / behaviours and sterility assurance elements.
To lead regulatory/customer audits wrt Microbiology operations and ensure that any actions generated for Microbiology are completed as per agreed timelines.
Responsible for enhancing overall compliance in Microbiology lab as per current regulatory expectations.
To perform any other work assigned by the head of the department based on need of organization.
To follow good documentation practices.
To adhere the c GMP standards.
To adhere to the organization rules and regulation.
To ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site.
To execute the sterile quality management review periodically.
Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas.
Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification.
Ensuring SOP adherence to clean room facility / utilities/ equipment / personnel qualifications whichever has a potential to impact the Sterility of the product.
Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product.
Oversee the media fill program.
Oversee the microbial OOS and OOT investigations, ensure microbial excursions are adequately handled and investigated.
Ensure microbial trend data is analysed and actions are taken proactively.
Review change controls related to Facility/ Process/ Utilities which may impact the current validated state with a focus on Sterility.
Ensuring periodic training of personnel involved in Sterility process and ensure practices to be followed while ensuring desired behaviour on shop floor.
Oversight of aseptic interventions, gowning qualifications, and contamination control strategies.
Ensure appropriate Data Integrity controls are applied and followed.
Responsible for allocation of work in Microbiology lab.
To monitor sample management system and planning of testing and release of raw material, in-process samples, validation samples, packing material and finished product from microbiology laboratory as per defined procedure.
Responsible for ensuring the testing and release of raw material, packing material and finished product as per agreed timelines.
Responsible for reviewing and approving the documents related to microbiological testing.
Responsible for managing Environmental monitoring, Utility monitoring (water/Compressed gases) program.
Inform to QC Head/Designee and Responsible for Reporting of OOS, OOT, Incident, deviation, CAPA and change control as per procedure.
Responsible for leading, investigating and closure of Microbiology Out of Specification Results and finalization of associated CAPA.
Responsible for reviewing of Standard Operating Procedures, imparting training on new/changed procedures and assuring implementation of the same in Microbiology lab.
Responsible for preparation of qualification/validation protocols, ensuring validations/qualifications are executed appropriately as per the procedures and reviewing/approving the validation/qualification reports.
Responsible for planning and management of Microbiology related activities during Aseptic Process Simulation.
Responsible for participation in activities related to Sterility Assurance of product/process.
To impart training to subordinates on aseptic techniques / behaviours and sterility assurance elements.
To lead regulatory/customer audits wrt Microbiology operations and ensure that any actions generated for Microbiology are completed as per agreed timelines.
Responsible for enhancing overall compliance in Microbiology lab as per current regulatory expectations.
To perform any other work assigned by the head of the department based on need of organization.
To follow good documentation practices.
To adhere the c GMP standards.
To adhere to the organization rules and regulation.
To ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site.
To execute the sterile quality management review periodically.
Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas.
Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification.
Ensuring SOP adherence to clean room facility / utilities/ equipment / personnel qualifications whichever has a potential to impact the Sterility of the product.
Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product.
Oversee the media fill program.
Oversee the microbial OOS and OOT investigations, ensure microbial excursions are adequately handled and investigated.
Ensure microbial trend data is analysed and actions are taken proactively.
Review change controls related to Facility/ Process/ Utilities which may impact the current validated state with a focus on Sterility.
Ensuring periodic training of personnel involved in Sterility process and ensure practices to be followed while ensuring desired behaviour on shop floor.
Oversight of aseptic interventions, gowning qualifications, and contamination control strategies.
Ensure appropriate Data Integrity controls are applied and followed.
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