Regulatory Compliance Specialist
1 week ago
Job Summary
At Global Recruiters of Dublin (GRN Dublin), we are seeking a highly skilled Regulatory Compliance Specialist to join our team. The ideal candidate will possess expertise in quality and compliance, with a strong background in the pharmaceutical industry.
About the Role
The Quality Assurance Compliance Specialist II will play a pivotal role in ensuring compliance with applicable regulatory standards, internal standards, and expectations for the development and reliable supply of quality medicines. This includes leading activities related to supplier qualification, change control, investigations and CAPA, complaints, Quality Risk Management, inspection readiness, and metrics.
Key Responsibilities
- Working across functions, participate in the implementation and maintenance of the site's quality system framework, including quality systems and processes necessary to enable the development and reliable supply of Client's generic medications to patients.
- Implement, track, trend, and analyze quality processes and systems across the product lifecycle, including but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Lead the assessment, qualification, and approval of suppliers.
- Participate in or lead internal self-assessment audits.
- Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.
- Working across functions to ensure compliant document control and training programs.
- Lead or participate in Quality Risk Management and Data Governance Processes as needed.
- Participate in activities to support regulatory agency inspections.
- Support site objectives with minimal supervision, including simple project management that may involve other functional areas.
- Promote a quality mindset and quality excellence approach to all activities.
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