Quality Assurance Strategist
This role is critical for operational readiness and ensuring smooth integration of new facilities or projects. A strong background in CAPEX project management within QA is essential, along with expertise in PQS, QMS, Validation, and Systems regulations.
Key Responsibilities:
* Collaborate with stakeholders to develop and execute a readiness plan that aligns GMP aspects of the new facility/project with business requirements.
* Ensure seamless integration of key GMP requirements, including procedural controls, facility controls, and training needs, to support timely transition from project phase to operational use in line with project schedules and site QMS.
* Provide support for Validation documentation as required.
* Manage risk and identify potential gaps, implementing strategies to mitigate them as necessary.
* Ensure all activities meet GMP regulations, site or corporate quality standards, and additional regulatory requirements.