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CMO Supply Chain Operations Associate
Confidential
- Cork, Cork, Ireland
- Cork, Cork, Ireland
Über
Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.
The successful candidate will support external manufacturing operations and clinical product supply activities, ensuring materials, drug product, finished goods and related inventory requirements are planned, coordinated and delivered accurately.
The successful candidate will work closely with Supply Chain, Quality, MSAT, external manufacturing partners and other internal stakeholders to support the supply of clinical products within a regulated environment.
Responsibilities: Manage ERP activities supporting external manufacturing operations, including production-related transactions and inventory management.
Monitor and manage inventory levels of drug substance, drug product, finished goods, components, bulk packs and samples at external manufacturing sites.
Coordinate purchase orders and invoices, ensuring accurate generation, tracking and follow-up.
Coordinate inbound and outbound shipments, including completion of shipping documentation and communication with relevant stakeholders.
Manage monthly inventory reconciliation activities and support inventory audits as the main point of contact.
Coordinate the supply of reference standards with external manufacturing partners.
Coordinate annual stability sample requirements with relevant internal teams and external manufacturing partners.
Maintain the accuracy of Tier 2 master data, including planning and GMP production recipes, quality parameters, dispensing and sourcing rules, planning attributes, formulas and routings.
Work cross-functionally to resolve short-term supply issues and support longer-term supply planning and performance objectives.
Support continuous improvement activities across supply chain operations, inventory management and external manufacturing processes.
Ensure all activities are completed in line with GMP, GDP and relevant quality requirements.
Other duties as assigned.
Qualifications & Experience: Bachelors degree in Life Sciences, Business, Supply Chain Management or a related discipline.
Minimum of 3 to 5 years experience in operations, supply chain or quality within a regulated manufacturing environment.
Experience in supply planning, inventory management and inventory reconciliation.
Experience supporting external manufacturing operations or contract manufacturing organisations would be an advantage.
Working knowledge of GxP regulations.
Experience with ERP systems and master data management.
Experience using CAPA, FMEA and RCA tools within a regulated manufacturing environment is desirable.
Experience supporting clinical packaging operations or clinical supply chain activities.
Knowledge of cold-chain logistics. xyswxtq
Experience coordinating shipments of pharmaceutical materials, drug product or clinical supplies.
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Sprachkenntnisse
- English
Hinweis für Nutzer
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