ASSISTANT MANAGER

Department Details

Role Summary

1.

Execute and oversee the environmental monitoring exercise, ensuring compliance with regulatory and site-specific microbiological control standards.

2.

Perform viable monitoring including air sampling, passive air sampling, surface sampling (swabbing & contact plate), and environmental condition tracking in cleanroom areas.

3.

Support deviation investigations, CAPA execution, and regulatory compliance efforts, ensuring continuous improvement and adherence to QMS requirements.

4.

Manage documentation, data trending, and audit readiness, ensuring environmental monitoring results are accurately recorded and reviewed.

5.

Collaborate with cross-functional teams, including QA, Engineering, and Manufacturing, to maintain contamination control and sterility assurance in classified areas.

Environmental Monitoring Operations :

Execute environmental monitoring for all classified cleanroom areas in PDP, PDS, Warehouses, QC Microbiology Laboratory, and Inoculum Laboratory per approved procedures.

Perform microbial sampling for equipment in PDP and PDS, ensuring compliance with sterility requirements.

Conduct gowning qualification and re-qualification for Grade B and Grade C cleanroom personnel

Preserve and manage microbial isolates obtained from environmental monitoring plates for identification and trending.

Assist in environmental qualification activities, incl. equipment qualification by performing microbiological sampling.

Maintain records for equipment, media, and consumables related to environmental monitoring, ensuring proper stock levels and audit readiness.

Report and investigate any non-conformance, OOL results related to environmental monitoring.

Participate in QMS activities, including deviation investigations, CAPA implementation, and change control execution.

Liaise with QA to ensure CAPA, deviation, and change control activities are closed within defined timelines.

Represent QCM in QMS meetings, addressing CAPA, deviations, and OOL issues raised by other departments.

Support preparation and submission of impact assessments related to environmental monitoring & microbiological ctrl.

Communicate and coordinate with CFT teams to support contamination control initiatives.

Support training programs on environmental monitoring, aseptic techniques, and contamination control for cleanroom personnel.

Assist in preparing regulatory responses related to audit compliance, laboratory incidents, and microbial risk assessments.

Participate in media fill activities for Drug Product sterility validation, ensuring environmental compliance during aseptic processing.

Equipment Qualification & Validation Support :

Ensure all QCM laboratory equipment, including temperature and humidity monitoring systems, are within calibration due dates and in validated states.

Perform daily equipment checks and logbook reviews, ensuring proper usage and maintenance.

Support fumigation activities in QCM Laboratory cleanroom areas, ensuring decontamination procedures are effectively executed.

Ensure laboratory waste disposal, glassware sterilization, and cleanroom hygiene activities comply with environmental safety requirements.

Documentation & Audit Readiness :

Prepare, review, and update protocols, specifications, SOPs, EOPs, and qualification documents as per regulatory and company requirements.

Maintain and update the QCM Master Index, ensuring controlled documents are properly issued and compliant with GDP requirements.

Review and approve executed documents, logbooks, and test reports, ensuring data accuracy, integrity, and traceability.

Ensure all environmental monitoring data, logs, and reports are complete and audit-ready for internal and external regulatory inspections.

Participate in internal and external audits, ensuring environmental monitoring procedures align with industry standards.

Key Responsibilities

1.

Execute and oversee the environmental monitoring exercise, ensuring compliance with regulatory and site-specific microbiological control standards.

2.

Perform viable monitoring including air sampling, passive air sampling, surface sampling (swabbing & contact plate), and environmental condition tracking in cleanroom areas.

3.

Support deviation investigations, CAPA execution, and regulatory compliance efforts, ensuring continuous improvement and adherence to QMS requirements.

4.

Manage documentation, data trending, and audit readiness, ensuring environmental monitoring results are accurately recorded and reviewed.

5.

Collaborate with cross-functional teams, including QA, Engineering, and Manufacturing, to maintain contamination control and sterility assurance in classified areas.

Environmental Monitoring Operations :

Execute environmental monitoring for all classified cleanroom areas in PDP, PDS, Warehouses, QC Microbiology Laboratory, and Inoculum Laboratory per approved procedures.

Perform microbial sampling for equipment in PDP and PDS, ensuring compliance with sterility requirements.

Conduct gowning qualification and re-qualification for Grade B and Grade C cleanroom personnel

Preserve and manage microbial isolates obtained from environmental monitoring plates for identification and trending.

Assist in environmental qualification activities, incl. equipment qualification by performing microbiological sampling.

Maintain records for equipment, media, and consumables related to environmental monitoring, ensuring proper stock levels and audit readiness.

Report and investigate any non-conformance, OOL results related to environmental monitoring.

Participate in QMS activities, including deviation investigations, CAPA implementation, and change control execution.

Liaise with QA to ensure CAPA, deviation, and change control activities are closed within defined timelines.

Represent QCM in QMS meetings, addressing CAPA, deviations, and OOL issues raised by other departments.

Support preparation and submission of impact assessments related to environmental monitoring & microbiological ctrl.

Communicate and coordinate with CFT teams to support contamination control initiatives.

Support training programs on environmental monitoring, aseptic techniques, and contamination control for cleanroom personnel.

Assist in preparing regulatory responses related to audit compliance, laboratory incidents, and microbial risk assessments.

Participate in media fill activities for Drug Product sterility validation, ensuring environmental compliance during aseptic processing.

Equipment Qualification & Validation Support :

Ensure all QCM laboratory equipment, including temperature and humidity monitoring systems, are within calibration due dates and in validated states.

Perform daily equipment checks and logbook reviews, ensuring proper usage and maintenance.

Support fumigation activities in QCM Laboratory cleanroom areas, ensuring decontamination procedures are effectively executed.

Ensure laboratory waste disposal, glassware sterilization, and cleanroom hygiene activities comply with environmental safety requirements.

Documentation & Audit Readiness :

Prepare, review, and update protocols, specifications, SOPs, EOPs, and qualification documents as per regulatory and company requirements.

Maintain and update the QCM Master Index, ensuring controlled documents are properly issued and compliant with GDP requirements.

Review and approve executed documents, logbooks, and test reports, ensuring data accuracy, integrity, and traceability.

Ensure all environmental monitoring data, logs, and reports are complete and audit-ready for internal and external regulatory inspections.

Participate in internal and external audits, ensuring environmental monitoring procedures align with industry standards.

Educational Qualifications

Required Education Qualification : Msc

Required Experience : 1 - 3 years