[GOV] Contract Prototyping Engineer [Translate Ideas to Outcomes] #HJC

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 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.

Requirement:

• Certificate in Business administration / Supply Chain / Logistics, ITE certificate, GCE “O” Level, GCE “A” Level.

• Min 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.

• 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.