1. JOB PURPOSE: To perform all critical manufacturing steps per production scheduling, material staging, equipment setup and GMP operations and monitors the process performance, assists in troubleshooting and adhering to GMP documentation and in order to ensure compliance to relevant regulations
2. KEY ACCOUNTABILITIES:
Description Policies, Processes & Procedures
Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner. Day-to-day Operations
Follows the day-to-day operations related to own job to ensure continuity of work Job Specific Accountabilities
Operates and performs line/equipment setup, cleaning and changeover activities that require the use of hand tools, removing and replacing machine parts, adjusting instrumental devices and cleaning parts in order to ensure compliance with cGMP, FDA, DEA, OSHA and other applicable regulations.
Monitors and documents production and equipment performance, troubleshoots operational problems, stages correct supplies at the packaging line and inspects packaging in order to optimize line/equipment operational tasks.
Maintains and ensures documentation, both written and electronic, is accurate, complete, and factual in order to ensure adherence to policies, procedures and regulatory guidelines.
Provides input and suggestions for process improvements as well as procedure writing and revision in order to increase Manufacturing efficiency.
Coordinates, performs, and reports all line testing for new formats or process changes and improvements in order to present to management.
Maintains and supports existing manufacturing processes in order to assist operators, supervisors, and manufacturing engineers.
Performs pre/post-line cleaning and clearance in order to ensure that no foreign products or components remain in the area.
Moves raw materials as required for mixing, weighing and storage to prepare cleaning solution batches and production batches designated by the department.
Provides first-line troubleshooting for manufacturing related issues in order to respond with appropriate analysis, impact assessment and path forward determination.
Interacts cross-functionally with Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaigns. Continuous Improvement
Contributes to the identification of opportunities for continuous improvement of processes and practices considering ‘international best practice’, improvement of business processes, cost reduction and productivity improvement. Reporting
Assists in the preparation of timely and accurate reports of the Manufacturing department to meet company and department requirements, policies and standards. Safety, Quality & Environment
Complies with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment. Related Assignments
Performs other related duties or assignments as directed.