Regulatory Affairs Coordinator
4 days ago
About the Team
\You will be part of a talented team dedicated to delivering high-quality products and services. Our team is passionate about innovation, customer satisfaction, and employee development.
\About the Job
\This is an exciting opportunity to join our team as a Quality Assurance Consultant. In this role, you will have the chance to work on various aspects of quality assurance, including implementing and maintaining our QMS, managing quality risk, and ensuring compliance with regulatory requirements.
\Responsibilities:
\- \
- Implementation and maintenance of QMS in local affiliates.\
- Quality risk management, including risk identification, analysis, communication, control, and escalation as required.\
- Complaint management, acting as the Local Complaint Coordinator for reporting, local assessment, and local investigation.\
- Change control management, QA assessment, site change control, QA review for change implementation and closure.\
- Deviation management for internal, external, and transport deviations.\
- CAPA management from deviations, internal audits, external audits, and self-inspections.\
- Management of authority inspections and self-inspections.\
- Local GxP surveillance and assessment.\
- Training management, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.\
- Local product release (local QP), shipment review of transport performance, goods receipt check, and deviation handling.\
- Oversight of GDP requirements for local warehousing and distribution.\
- Shipping lane qualification and local transport performance of secondary distribution.\
- Secondary distribution transport performance review.\
- Return management, including QA evaluation against return criteria and collaboration with distributors.\
- Product recall management, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.\
- GxP suppliers management, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.\
- Local repackaging and relabeling, including change management, protocol, execution, QA review, and release.\
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