Reporting to the Senior Manager, QA Compliance Materials Management, the Specialist will support the material qualification and release activities for its biologic's commercial portfolio and clinical pipeline.
Key Responsibilities
* 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) Certificates
o Other associated documentation
* Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.
* Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Qualifications & Experience
The successful candidate must possess:
* 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.