Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
SUMMARY OF ESSENTIAL FUNCTIONS
The Operations Associate will be responsible for supporting the label printing and packaging team in the execution of label printing operations and secondary packaging of pharmaceutical products for clinical trials.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES
General
- Perform housekeeping activities assigned by M&P Supervisor and/or designee.
- Perform assigned tasks in compliance with Good Manufacturing Practices (GMP), site Standard Operating Procedures (SOPs) and policies at all times.
- Complete documentation in compliance with Good Documentation Practice (GDP) requirements.
- When the need arises or when required by Management, to perform other tasks or duties assigned by the M&P Supervisor and/or designee. If applicable, training will be provided to support this multi-skilled flexibility.
Secondary Packaging of Pharmaceutical Products for Clinical Trials
- Perform clearance of packaging booth in preparation for packaging operations.
- Pick material and components for issuance into packaging operations.
- Labelling and assembly of kit components in accordance with GMP, SOPs, product specifications and approved packaging diagram to ensure the production of Finished Clinical Trial Kits that comply with quality standards.
Label Printing and Inspection
- Perform clearance of label printing booth in preparation for label printing and/or inspection operations.
- Setting up label stock and thermal ribbons as per approved specifications to maintain consistent label printing performance and quality.
- Perform label printing in accordance with approved procedures to ensure printed labels meet the established quality standards.
- Conduct detailed inspection of printed labels to identify print defects and segregate labels which fail to meet defined quality standards.
- Complete label printing documentation in compliance with SOPs and GDP.
POSITION REQUIREMENTS
Education and Experience:
- Minimum GCE “O” Levels
- Familiarity with material handling equipment and inventory practices.
- Computer literacy is essential for recording data and using production systems.
Knowledge/Skill Requirements:
- The ability to understand both written and oral processes and procedures and the ability to interact with other departments is required.
- Prior experience conducting labelling and packaging tasks within cold/freezer environment (2 to 8°c / -15 to -25°C) for extended periods is preferred.
- Detail-oriented with good organizational and teamwork abilities.
- Safety-consciousness with a proactive attitude toward learning and improvement.
- Ability to perform physical tasks.
- Ideally 2 years' experience in a Clinical Packaging and Logistics environment.