Job Description
Description:experience of 4-5 years in the same position preferred in Beta lactum Dry Powder Injectables and Dialysis fluids in Powder and Liquid forms.
Key Responsibilities:
Production Operations
Plan organize and manage the overall production activities for the and nbsp;Dry Powder Injectable section.
Ensure production targets are achieved as per monthly and annual schedules.
Oversee and nbsp;batch manufacturing and nbsp;filling and nbsp;lyophilization and and nbsp;packaging and nbsp;operations.
Review and approve and nbsp;BMRs (Batch Manufacturing Records) and nbsp;SOPs and production documents.
Coordinate with QA QC Engineering and Stores for smooth plant operations.
Compliance and amp; Quality
Ensure compliance with and nbsp;cGMP WHO USFDA and other international regulatory standards.
Prepare and face and nbsp;regulatory audits and nbsp;and client inspections.
Ensure proper documentation equipment qualification and process validation.
Monitor and maintain and nbsp;cleanroom standards and nbsp;and environmental controls.
People and amp; Resource Management
Lead and mentor the and nbsp;production team ensuring training motivation and performance management.
Plan manpower requirements and ensure optimum utilization of workforce and resources.
Promote a culture of and nbsp;discipline safety and continuous improvement.
Safety and amp; Maintenance
Ensure strict adherence to and nbsp;EHS (Environment Health and amp; Safety) and nbsp;norms and aseptic practices.
Coordinate preventive maintenance of machines and utilities with the Engineering department.
Implement corrective and preventive actions for deviations and breakdowns.
Process Improvement and amp; Cost Control
Drive and nbsp;process optimization yield improvement and and nbsp;waste reduction and nbsp;initiatives.
Monitor production costs and ensure efficient utilization of materials and energy.
Implement lean manufacturing and Kaizen practices.
Key Skills and amp; Competencies:
Strong technical expertise in and nbsp;Dry Powder Injectable manufacturing and aseptic operations.
In-depth knowledge of and nbsp;GMP documentation validation and regulatory compliance.
Excellent leadership communication and team management skills.
Analytical and problem-solving mindset with attention to detail.
Proficient in and nbsp;MS Office SAP/ERP systems and production data analysis.
Preferred Background:
Experience in and nbsp;parenteral formulations particularly and nbsp;Dry Powder Injectables (Cephalosporin / Non-Cephalosporin).
Exposure to and nbsp;regulatory audits (WHO-GMP USFDA EU MHRA etc.).
Hands-on experience with and nbsp;lyophilization filling line and cleanroom management.
Job DescriptionDescription:experience of 4-5 years in the same position preferred in Beta lactum Dry Powder Injectables and Dialysis fluids in Powder and Liquid forms.Key Responsibilities:Production OperationsPlan organize and manage the overall production activities for the and nbsp;Dry Powder Inje...
Job Description
Description:experience of 4-5 years in the same position preferred in Beta lactum Dry Powder Injectables and Dialysis fluids in Powder and Liquid forms.
Key Responsibilities:
Production Operations
Plan organize and manage the overall production activities for the and nbsp;Dry Powder Injectable section.
Ensure production targets are achieved as per monthly and annual schedules.
Oversee and nbsp;batch manufacturing and nbsp;filling and nbsp;lyophilization and and nbsp;packaging and nbsp;operations.
Review and approve and nbsp;BMRs (Batch Manufacturing Records) and nbsp;SOPs and production documents.
Coordinate with QA QC Engineering and Stores for smooth plant operations.
Compliance and amp; Quality
Ensure compliance with and nbsp;cGMP WHO USFDA and other international regulatory standards.
Prepare and face and nbsp;regulatory audits and nbsp;and client inspections.
Ensure proper documentation equipment qualification and process validation.
Monitor and maintain and nbsp;cleanroom standards and nbsp;and environmental controls.
People and amp; Resource Management
Lead and mentor the and nbsp;production team ensuring training motivation and performance management.
Plan manpower requirements and ensure optimum utilization of workforce and resources.
Promote a culture of and nbsp;discipline safety and continuous improvement.
Safety and amp; Maintenance
Ensure strict adherence to and nbsp;EHS (Environment Health and amp; Safety) and nbsp;norms and aseptic practices.
Coordinate preventive maintenance of machines and utilities with the Engineering department.
Implement corrective and preventive actions for deviations and breakdowns.
Process Improvement and amp; Cost Control
Drive and nbsp;process optimization yield improvement and and nbsp;waste reduction and nbsp;initiatives.
Monitor production costs and ensure efficient utilization of materials and energy.
Implement lean manufacturing and Kaizen practices.
Key Skills and amp; Competencies:
Strong technical expertise in and nbsp;Dry Powder Injectable manufacturing and aseptic operations.
In-depth knowledge of and nbsp;GMP documentation validation and regulatory compliance.
Excellent leadership communication and team management skills.
Analytical and problem-solving mindset with attention to detail.
Proficient in and nbsp;MS Office SAP/ERP systems and production data analysis.
Preferred Background:
Experience in and nbsp;parenteral formulations particularly and nbsp;Dry Powder Injectables (Cephalosporin / Non-Cephalosporin).
Exposure to and nbsp;regulatory audits (WHO-GMP USFDA EU MHRA etc.).
Hands-on experience with and nbsp;lyophilization filling line and cleanroom management.
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