Senior Specialist Contract Opportunity in Dublin
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:
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 is a distinct advantage
* Ability to work independently and as part of a team
* Excellent communication, presentation, time management, and organizational skills
* Ability to multi-task and meet accelerated timelines
* Stamp 1 G or Stamp 4 visa required for applicants interested in contracting opportunities within the pharmaceutical sector in Ireland