QA Regulatory Compliance Specialist
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Role
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
Maintenance of Approved CMO list for Clinical Supply Chain
Ensur...