Description

JOB DESCRIPTION

This role is responsible for performing a variety of tasks related to the operation and maintenance of autoclave equipment within a regulated pharmaceutical manufacturing environment. The role operates autoclave systems to ensure all manufacturing equipment, materials, and products are properly sterilized in compliance with pharmaceutical quality standards. The role handles equipment and materials in compliance with stringent quality and safety standards. It involves executing standard operating procedures to meet current Good Manufacturing Practices and maintaining accurate records as required by regulatory bodies. The position ensures all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines. The role contributes to process improvement initiatives by participating in functional team projects aimed at enhancing quality, cost efficiency, and scheduling effectiveness. It supports the optimization of resource utilization while minimizing costs and maintaining the highest quality standards in pharmaceutical manufacturing. The role plays a key role in sustaining a compliant and efficient autoclave operation within a global pharmaceutical organization.

Essential Functions

Operate autoclave equipment to sterilize manufacturing materials, equipment, and products in accordance with approved procedures and validated cycles
Handle manufacturing equipment and materials with appropriate care and documentation to ensure sterility and compliance
Execute standard operating procedures to ensure compliance with current Good Manufacturing Practices for autoclave operations
Maintain accurate sterilization records, batch documentation, and autoclave logs as required by regulatory and quality standards
Perform general maintenance tasks on autoclave equipment and related machinery as needed
Conduct area cleaning and sanitization activities to maintain manufacturing area standards
Ensure all autoclave activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines
Monitor autoclave cycle parameters, temperature, pressure, and time to ensure validated sterilization conditions are met
Participate in functional team projects focused on developing process improvement methods, solutions, and procedures to enhance quality and scheduling

Additional Responsibilities

QUALIFICATIONS

Education

B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred

Experience:

1 year or more in 1 - 4 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.

Officer, Autoclave