An External Manufacturing Specialist is required by CareerWise Recruitment for our Dublin based client.
The External Manufacturing Specialist oversees all aspects of drug product contract manufacturing operations
Role of this position
- Coordinates DP manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities, and enlisting support from others who will provide any required associated reports and technical expertise.
- Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
- Supports all investigations which concern external manufacturing and associated shipping operations.
- Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers and business partners.
- Ability to travel up to 25% (domestic and international).
- Requires a BS/BA in a scientific, or engineering discipline and 3+ years' experience of working in a GMP environment.
- Working knowledge of industry practices and regulations (e.g. GxP, FDA regulations), familiarity with ICH guidelines and EU regulations.
- Experience in collaborating with CMOs is preferred.
Please call Lisa Casserly today for further information on 091-339136 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)