Regulatory Compliance Coordinator
5 days ago
Overview:
We're currently recruiting for an exciting opportunity within a Pharmaceutical organization based in Ireland. This position is ideal for professionals seeking to join a leading multinational that excels in its field.
Key Responsibilities:
- Understand and progress change controls using IPI and Veeva Change Control Systems, ensuring adherence to site and global processes.
- Assume responsibility as a Change Control SME, keeping updated with regulatory updates and attending local COP Meetings.
- Collaborate with the team to draft and prepare change controls, ensuring timely completion and high-quality outcomes.
- Promote effective communication during change control meetings, fostering collaboration among stakeholders.
- Maintain accurate and up-to-date change control records, identifying areas for improvement and implementing metrics-driven solutions.
- Liaise with colleagues across functions to ensure projects are executed efficiently, meeting project deadlines.
- Provide subject matter expertise on batch release, annual product review, and regulatory filings, driving process enhancements.
Qualifications:
- Significant experience in change control management, with a focus on IPI and Veeva systems.
- Proven ability to add substantial value to the organization in a senior role.
- Background in engineering and/or validation, with a history of successfully managing change controls in sterile manufacturing environments.
- Strong leadership skills, particularly in navigating change, would be beneficial.
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