Required Competencies-Knowledge, Skills, and Abilities:
o Knowledge of cGMP/GDP/Pharmaceutical regulations
o Knowledge and experience with setting up GMP warehouse and ERP system high desirable
o Knowledge warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation and qualification
o Proficiency in Oracle ERP systems / WMS Applications and analytics tools
o Proficiency in MS Office applications
o Excellent written and verbal communication skills
o Excellent organizational and time management skills
o Ability to work in a matrix environment
o Pro-active personality with an eye for anticipation and continuous improvement
Education & Experience:
o Associate or Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields.
o 5-7 years of relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
o 4+ years experience in warehousing, manufacturing and supply chain areas.
o An equivalent combination of education, experience and training may substitute.
Essential Functions:
o Support early phase clinical trial Biologics warehousing activities
o Manage daily operational activities associated with kitting, receiving of raw materials and consumables shipments, all movement of materials through the Biologics supply chain network and preparation for drug product shipments
o Ensure an excellent coordination in the case of extraordinary events that have an impact on the logistical activities with the different stakeholders (QC, QA, warehouse, production supplier)
o Engage in various groups to manage and expedite receipt along with ensuring appropriate sampling / inspection of incoming materials
o Create and implement documentation and procedures to maintain warehouse in the state of compliance at all times.
o Write and maintain the Purchasing specifications, ensures the follow-up through the integrated approval process system and the submission to the supplier.
o Manage efficiently the inventory levels and initiates and follows-up materials destructions, manage the retest execution process
o Lead and manage the development of corrective and preventative actions, deviation responses and investigations for warehouse operations
o Develop, maintain and actively manage relationships with customers and external partners to ensure optimize total cost of ownership
o Technical writing capability
o Advanced warehouse management system experience
o Supervisory skills to provide direction and support of warehouse material handler positions
o Provide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulations
o Develop business continuity plans to ensure sustainable operations
o Develop dashboard to monitor performance against metrics and KPIs