Our client is a world leader in providing drug development and manufacturing, clinical trial, and packaging technology services to the pharmaceutical industry.
Currently, they require a driven individual to join their high-performing Project Management Team.
The Project Manager - Labelling will support customer (clinical) projects to ensure that project goals and objectives are accomplished within the appropriate time frames, budget, and in accordance with customer expectations and pharmaceutical regulatory requirements.
Along with the above, the Project Manager - Labelling will have responsibility for the overall management and set up of production process, budgets and critical materials for the projects assigned to themselves. Specifically, this will involve working to provide equipment/materials quotes for the specific project, preparing Master Batch Records (MBRs), Finished Product Specifications (FP Specs), label review and approval, specifying and ordering critical materials to be procured for the
project, assisting with GMP Agreements and coordinating the production activities to deliver
the clients requested outcomes in line with the agreements.
The Project Manager - Labelling will work with the Production Manager and Head of Projects to schedule the manufacturing / labelling activities.
Essential skills and experience:
- Tertiary qualification - Science, Pharmaceutical Sciences (additional business orientated qualification highly regarded)
- At least 3 years related experience - Pharmaceutical industry highly regarded
- In-depth understanding of clinical trials and supplies
- Excellent mathematical skills
- Advanced computer skills - Ability to perform the most complex computer tasks and operate various computer programs
- Excellent communication skills - Both written and verbal | Strong ability to connect and communicate with staff from all areas of the business
- High attention to detail and strong ability to prioritise and organise workload
- A positive can-do attitude
Primary responsibilities of this role:
- Accountable for overall project management for assigned projects/customers using appropriate project planning tools. Communicates milestones, critical path activities, and assigns internal and external responsibility to ensure the project achieves all deliverables per the customer requirements and agreed upon timelines
- Primary customer contact for clinical packaging and/or distribution activities and relationship management with the customer project teams for assigned projects/customers
- Responsible for leading Clinical Project Team and Technical Kick-Off Meetings for assigned projects
- Provide support to business development and estimation regarding new quotations and resupplies
- Assessment of clinical protocols, study specifications, contracts, and other documentation to ensure we mitigate risk and provide our clients with the best service and experience
- Creates and reviews project specific documentation including master batch records, finished product specifications, sample shipment request forms, printing and issuance form requests, bill of materials spreadsheets
- Ensures labels design and text is in accordance with the study set up
- Forecasting and managing project expenses in adherence with the project budget
- Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests
- Hard allocates lot specific bulk and materials to the production labelling activity
- Review and approve internal customer-based specifications for packaging components and processes
- Provide suggestions for packaging solutions in the areas of design and specification management
If your skills and experience match the above criteria, then please apply with your covering letter and resume in Word Format.
Questions can be directed to Aya Inazato at Fuse Recruitment on 0423 505 950.