Raw Materials Coordinator Role
We are seeking a skilled Raw Materials Coordinator to manage the introduction of new GMP raw materials for the manufacture of bulk drug substances.
* Coordinate requirements and oversee project plans for new materials related to multiple product introductions.
* Ensure that all materials have SAP master data created, material risk assessments and specifications completed, and are tested and released by QC and QA in line with tech transfer and manufacturing schedules.
Main Responsibilities:
- Identify requirements and Suppliers.
- Coordinate with Technical Services who will provide process descriptions and create bills of materials and with the strategic sourcing team and buyer to identify suitable suppliers, grades and pack sizes according to process requirements and following standard operating procedures for NMI.
- Work with Technical Services, Operations and Strategic Sourcing to ensure that the correct quantities are estimated to support technical studies, shakedown and engineering batches each new product introduction up to and including the process performance qualification batches (PPQ).
- Attend Material Review Board (MRB), Supplier Review board (SRB) and qualification tracker meetings to ensure material and supplier is qualified for use.
- Qualify new Vendors and New Materials.
- Coordinate with QA, QC and Technical Services who are responsible for qualifying and adding new vendors and/or materials to the approved vendor list.
- Coordinate and plan the generation of technical risk assessments and material specifications by Technical Services and QC respectively.
- Purchasing.
- Coordinate with the Buyer to complete purchasing activities for all raw materials and components on the BOM, as well as any new consumables via the on-site vendor managed inventory service provider.
- Work with Manufacturing and other site departments to understand future material needs and develop a purchasing schedule.
- Support the Buyer as required to process purchase requisitions, enter purchase orders in SAP, and generate reports for upper management review.
- Planning/scheduling.
- Produce BDS master schedules/ plans as assigned and in conjunction with the buyer ensure that these are translated into SAP process orders in order to initiate MRP.
- Create process orders in SAP to initiate batch manufacture and coordinate with the finite scheduler to execute the BDS production schedule.
- Generate new material request forms to initiate qualification of the material.
- Update BOM and MES where required to support the manufacturing line.
- Chair weekly calls to support the NMI production for technology transfer.