About this role
Description:
This role is responsible for managing and coordinating manufacturing operations within the oncology production area, ensuring that all processing and assembly activities related to oncology pharmaceutical products are conducted in strict compliance with specialized regulatory requirements, safety protocols, and quality standards. The incumbent oversees the operation of manufacturing equipment used in oncology product manufacturing and ensures that hazardous raw materials and intermediate products are handled in accordance with containment and safety procedures. The position requires the application of Standard Operating Procedures and current Good Manufacturing Practices to maintain product integrity, personnel safety, and regulatory compliance in a highly controlled manufacturing environment. The role involves developing and implementing production schedules to ensure the effective utilization of labor, equipment, and resources in the oncology manufacturing area. The incumbent is accountable for maintaining accurate batch records and production documentation in line with GMP requirements. The position contributes to process improvement initiatives aimed at enhancing oncology manufacturing quality, reducing costs, and optimizing production scheduling. The role also involves leading a team and ensuring that all oncology manufacturing activities meet output and quality objectives within the defined timelines.
Essential Functions:
- Manage and coordinate oncology pharmaceutical manufacturing operations in compliance with GMP, containment, and specialized safety standards.
- Oversee the operation and maintenance of manufacturing equipment used in oncology product production to ensure continuous and efficient output.
- Handle hazardous raw materials, cytotoxic compounds, and intermediate oncology products in accordance with containment protocols and established safety and quality standards.
- Develop and implement production schedules to ensure effective utilization of labor, tools, and equipment in the oncology manufacturing area.
- Maintain accurate batch records and production documentation in compliance with current Good Manufacturing Practices and regulatory requirements.
- Ensure all oncology manufacturing activities comply with applicable regulatory requirements including FDA, EMA, and occupational health and safety regulations.
- Monitor production output against quality objectives and initiate corrective and preventive actions for any deviations identified.
- Enforce containment and personal protective equipment protocols to ensure personnel safety in the oncology manufacturing environment.
- Lead team participation in process improvement projects to develop methods and procedures that enhance oncology manufacturing quality and reduce costs.
Additional Responsibilities:
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 8 years or more in 8 - 10 Years
Specialized Knowledge: Licenses: