About the Company
A leading pharmaceutical company is looking for an Quality Assurance Operation Contractors 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 an 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 an Quality Assurance Operations
- Bachelor’s degree Science or Technical
- 8-10 years 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 an 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
- Or if the job isn’t quite right but you are looking for something similar, please get in touch.
