Pre-Production Associate

CATALENT CTS (SINGAPORE) PRIVATE LIMITED; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading global contract development and manufacturing organization is seeking a dedicated individual to coordinate pre-production activities for clinical trial supplies. The role involves liaising between Project Management and Operations, ensuring timely execution of packaging tasks while adhering to GMP standards. Ideal candidates will have a background in business administration or supply chain, along with relevant experience in pharmaceuticals. Strong organizational and communication skills are essential for success in this dynamic environment.

Qualifications

• 3+ years experience in pharmaceuticals manufacturing/packaging.
• Knowledge of cGMPs and relevant Safety Regulations.

Responsibilities

• Plan and prioritize pre-production aspects of packaging.
• Identify and implement improvements in quality and safety.
• Ensure compliance with Good Manufacturing Practice.

Skills

Time Management

Organizational skills

Communication

Analytical skills

Education

Certificate in Business administration

Supply Chain

Logistics

GCE 'O' Level

GCE 'A' Level

Job description

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

Job Description:

The coordination of activities required to complete the pre-production elements of project execution. To become the main point of contact and the link between Project Management and Operations in all Secondary Packaging activities.

KEY RESPONSIBILITIES

• Plan and prioritize the Pre-Production aspects of the packaging of clinical trial supplies, including:
  • Creation of accurate Pack Designs that reflect the needs of the client and meet GMP requirements.
  • Ensure appropriate QIF’s are raised in the event that final Pack Designs differ from the original contract.
  • Procurement with Approved vendors to purchase required packaging components, label stock and equipment in a timely manner to hit Production timelines
  • Working closely with the Project Management team to ensure good understanding of the projects and that all client required documentation is received and approved in a timely manner e.g. Label Approvals
  • Working with the Centre of Excellence for Label Printing (Catalent SCH) to organize the set-up of new labels within the Clinicopia label printing system and to set-up local label printing jobs
  • Set-up of packaging configurations and packaging jobs within the Global Scan Assembly system
  • Creation of accurate packaging and labeling documentation to meet the needs of both the client and regulatory GMP requirements including Label Print Forms (LPF’s) and Batch Records (automated via SupplyFlex and manual)
  • Creation of example packs and blinding samples in line with SOP’s
• Identify and implement cost, quality, service and safety improvements within the Pre-Production areas
• Identify continuous improvement opportunities & delivery of improvement actions to continually enhance the performance of the team
• Review/approve documentation prepared by other staff
• Ensure that all work is carried out in compliance with current Good Manufacturing Practice and Health and Safety requirements
• Any other duties which may properly be assigned to this post.

POSITION REQUIREMENTS:

• Certificate in Business administration / Supply Chain / Logistics, ITE certificate, GCE “O” Level, GCE “A” Level
• >3 years relevant work experience gained in pharmaceuticals manufacturing/packaging/clinical supply/supply chain operations or project management
• Knowledge and experience in cGMPs and relevant Safety Regulations
• Patient First mindset, adopting a right first-time approach ensuring all commitments are met in a timely manner
• Good Time Management / Organizational skills adopting a committed approach to providing a high level of customer service
• Ability to learn, analytical and retain technical knowledge and information
• Excellent communication skills with both internal and external customers of all levels
• Demonstrate ability to work effectively in a team environment, manage multiple priorities, exercise sound judgment, flexibility and work well under pressure whilst still producing accurate and timely work