Job Summary
The Senior Specialist, QA Compliance Materials Management will support the material qualification and release activities for our biologic's commercial portfolio and clinical pipeline. This role requires strong knowledge of cGMP requirements and excellent communication skills.
The Role
* Material Qualification Documentation: Prepare, review and approve Material Qualification Documentation to ensure compliance with regulations.
* QA Disposition: Perform QA disposition of raw materials, level 1 & level 2 consumables to ensure quality standards are met.
* Procedure Authoring: Author, review and approve QA-related procedures to maintain regulatory compliance.
* Biologics Manufacture Review: Perform QA review, assessment and approval activities for Biologics Manufacture, including change controls, deviations/investigations, supplier investigations, CAPAs, SCN, TSE Certificates and other associated documentation.
* Team Collaboration: Collaborate with the QA Compliance Materials Management team on support activities and Operational Excellence initiatives.
* Operational Excellence: Support the establishment of Operational Excellence initiatives such as 5S, Std Work, LSW, Kaizen and Problem Solving.
Qualifications and Experience
* Education: BSc in Science or related discipline.
* Certifications: Clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
* Skills: Knowledge of material qualification, SAP, strong communication and presentation skills, time management and organizational skills, ability to multi-task.
* Personal Qualities: Ability to work independently and collaboratively within a team matrix to meet accelerated timelines.
About Next Generation Recruitment
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