About Our Company
A leading pharmaceutical company is seeking a Quality Assurance Operations Contractor to join their Dunboyne site for an 11-month contract due to continued growth and expansion.
Your New Role:
* Drive daily cross-functional team efforts to resolve compliance issues and achieve project milestones.
* Investigate and assess risks related to deviations, complaints, and changes, ensuring timely corrective actions.
* Ensure strong operational compliance focus linked with cGMP regulations.
Key Responsibilities:
* Review and approve Change Controls, Deviations/CAPAs, SOPs, and documentation for GMP and site compliance.
* Oversee qualification/validation, technical transfers, regulatory approvals, and operations to ensure quality standards.
* Handle QA duties for product release, including incoming material and eBR review prior to QP release.
* Stay updated on new regulatory guidance and industry best practices, implementing necessary quality system changes.
Requirements:
* Bachelor's degree in Science or Technical field.
* 8-10 years of experience ideally in Quality Assurance, Quality Control, or Project Management.
* Demonstrate experience in QRM, Investigations, Problem solving, and quality management systems such as Veeva and SAP.
What We Offer:
* Hourly rate based on DOE.
* 12-month contract.
* Hybrid opportunity.