Job Overview
The role is focused on operational readiness, specifically in the GMP aspects of new facilities or projects.
The QA Lead Specialist will ensure that all GMP requirements are aligned and functional to support business needs.
This involves expert knowledge of PQS, QMS, Validation, and Systems regulations as well as previous experience in clinical through to commercial manufacturing.
* Developing a readiness plan with key stakeholders
* Ensuring integration of key GMP requirements
* Validating documentation and identifying potential gaps
Key Responsibilities
* PQS, QMS, Validation, and Systems Regulations: Expert knowledge of these areas and how they apply to quality assurance
* Clinical to Commercial Manufacturing Experience: Previous experience working in this area, understanding the unique challenges and requirements
* Operational Readiness: Ensuring new facilities or projects are ready for business use
Benefits
This role offers a unique opportunity to work in a fast-paced environment, develop expertise in quality assurance, and contribute to the success of the organization.
About the Role
This is a contract position, lasting 12 months. The successful candidate will be responsible for ensuring operational readiness, developing a readiness plan, validating documentation, and identifying potential gaps.