Regulatory Compliance Specialist
2 weeks ago
Regulatory Compliance Specialist
\Via our collective expertise, we empower people to live healthier at every stage of life.
\We act courageously and advance sustainable operations by leveraging our global portfolio, which includes best-in-class products across a wide range of therapeutic areas.
\This role will make an impact:
\- Manage GMP documentation, review, approval, and system used onsite.
- Participate in training initiatives and prepare delivery of GMP training modules and other training as required.
- Prepare Annual Product Quality Review reports.
- Effectively manage process deviation systems and timely investigation reports.
- Ensure timely change control approvals and CAPA management.
- Assist in preparation for regulatory audits and generate quality metrics monthly.
- Participate in GMP projects within QA and onsite.
- Perform all activities according to current Good Manufacturing Practice.
You will be working in a clean and tidy environment, with the ability to work independently and as part of a team.
\The ideal candidate has experience managing deviations, change controls, CAPAs, and compiling annual product quality reviews. They have strong problem-solving skills and attention to detail, with proficiency in speaking, comprehending, reading, and writing English.
\We are committed to creating a collaborative culture that fosters courage and resilience.
\You will also have access to excellent career progression opportunities and work-life balance initiatives.
\Diversity and inclusion are essential to our mission.
\We believe diversity can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.
\Our sustainability efforts aim to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life.
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