About the Company
A leading pharmaceutical company is looking for a Quality Assurance Operators Contractor to join their Dunboyne site on an 11-month contract due to continued growth and expansion. You will be responsible for ensuring strong operational compliance focus linked with cGMP regulations.
About your new job as a Quality Assurance Operations
* Lead and Collaborate: Drive daily cross-functional team efforts to resolve compliance issues and achieve project milestones.
* Investigate and Assess Risks: Support investigations and risk assessments related to deviations, complaints, and changes, ensuring timely corrective actions.
* Ensure Compliance: 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.
* Contribute to QA training materials and provide SME training on SOPs for the operations team.
* Assist with creating and updating QA policies, SOPs, and reports in line with site requirements.
* Identify and implement continuous improvements and efficiency gains in quality processes.
* Participate in risk management activities in line with industry best practices.
* Support the internal audit program, performing audits as needed.
* Build strong relationships with management and colleagues to promote a compliant culture.
* Timely escalate compliance risks to management.
What skill/experience you need as a Quality Assurance Operations
* Bachelor’s degree in Science or Technical
* 8-10 years of experience ideally in Quality Assurance, Quality Control
* Project Manager capability
* Demonstrate experience in QRM, Investigations, Problem solving
* Experience in quality management systems such as Veeva, SAP
What’s on offer for you as a Quality Assurance Operations
* Hourly Rate DOE
* 12-month Contract
* Hybrid opportunity
What’s next
* Apply now by clicking “Apply Now” or contact me at 021 484 7135.
* If the job isn’t quite right but you are looking for something similar, please get in touch.
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