External Manufacturing Compliance Specialist
In this role you will be a key member of the External Manufacturing Team who collaborates with various teams to ensure business objectives are met through effective support of Drug Product manufacturing activities.
Key duties will include:
· Provide support to Drug Product Manufacturing operations team to ensure world-class DP supply quality, delivery, and efficiency
· Organises logistic documentation to enable Drug product shipments
· Executes Drug product compliance activities including but not limited to, change controls, investigations and CAPA’s Management of audit CAPA closure
· Maintain, update and provide status of Drug Product Manufacturing activities via schedules and checklists Tracking trending and monitoring a wide variety of External Manufacturing data, preparing reports analysing data and making recommendations proactively with minimal supervision
The successful candidate will
· thrive in a multifaceted and fast-paced environment
· Will possess excellent verbal and written communication skills
· enjoy problem solving
· successfully build and develop strategic partnerships
· demonstrate an ability to work within a successful team
· you should have a BS/BA in scientific or engineering discipline with 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products) or equivalent combination of education and experience.
For more information, please contact Clodagh D’Arcy on 087 3470221 or email details to [email protected]