Senior Officer, Manufacturing Process Operations

Description:

This role is responsible for performing a variety of tasks related to the processing and assembly of ingredients and pharmaceutical products within a regulated manufacturing environment at a senior operational level. The incumbent operates general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus and brings enhanced experience to support pharmaceutical production operations. The role handles raw materials and intermediate or finished products 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 production. The incumbent plays a key role in sustaining a compliant and efficient manufacturing process operations function within a global pharmaceutical organization.

Essential Functions:

• Operate general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus in accordance with approved procedures with a higher level of proficiency.
• Handle raw materials, intermediate products, and finished pharmaceutical goods with appropriate care and documentation.
• Execute standard operating procedures to ensure compliance with current Good Manufacturing Practices at all times.
• Maintain accurate batch documentation records and production logs as required by regulatory and quality standards.
• Perform general maintenance tasks on pumps, homogenizers, filter presses, tablet compression machines, and other production equipment.
• Conduct area cleaning and sanitization activities to maintain manufacturing area standards.
• Ensure all production activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines.
• Participate in functional team projects focused on developing process improvement methods, solutions, and procedures to enhance quality and scheduling.
• Provide guidance and support to junior team members on GMP compliance and manufacturing procedures.

Additional Responsibilities: