Job Description
A great contract opportunity for a Senior Specialist to join a Dublin-based Biopharmaceutical company.
About the Project
* Preparation, review, and approval of Material Qualification Documentation
* QA disposition of raw materials, level 1 & level 2 consumables
* Authoring, review, and approval of QA-related procedures
* QA review, assessment, and approval activities for Biologics Manufacture, as applicable, for:
o Change controls
o Deviations/Investigations
o Supplier Investigations
o CAPAs
o Supplier Change Notifications (SCN)
o TSE (Transmissible Spongiform Encephalopathy) Certificate
About You
* BSc in Science or related discipline with QA or related experience in a Biologics or Pharmaceutical environment
* A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
* Knowledge of material qualification & SAP would be a distinct advantage
* Required to work on his/her own initiative in addition to working as part of a team
* Must be able to work across a team matrix to meet accelerated timelines
* Excellent communication and presentation skills are essential
* Excellent time management and organizational skills along with a proven ability to multi-task