Description

This role is responsible for performing a variety of tasks related to the cleaning and preparation of vials and containers used in pharmaceutical manufacturing within a regulated environment. The role operates vial washing equipment and related machinery to ensure all containers are properly cleaned and prepared for use in sterile pharmaceutical production. The role handles vials and related 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 vial washing operation within a global pharmaceutical organization.

Essential Functions:

• Operate vial washing equipment and related machinery to clean and prepare pharmaceutical containers in accordance with approved procedures
• Handle vials, containers, and related materials with appropriate care and documentation to ensure cleanliness and compliance
• Execute standard operating procedures to ensure compliance with current Good Manufacturing Practices for vial washing operations
• Maintain accurate batch documentation records and washing logs as required by regulatory and quality standards
• Perform general maintenance tasks on vial washing equipment and related machinery as needed
• Conduct area cleaning and sanitization activities to maintain cleanroom and manufacturing area standards
• Ensure all vial washing activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines
• Monitor washing cycle parameters and report any deviations or non-conformances to supervisors promptly

Participate in functional team projects focused on developing process improvement methods, solutions, and procedures to enhance quality and scheduling

• Additional Responsibilities:

Education

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

Experience

• 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses: