Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Description
JOB 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
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 8 years or more in 8 - 10 Years
Specialized Knowledge: Licenses:
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
About The Team
The
Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
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