Regulatory Compliance Specialist
6 days ago
The Quality Assurance Officer will be responsible for ensuring the Group's quality systems comply with local regulations and are aligned with quality directives.
Key Responsibilities- Oversee Change Control processes, ensuring they are in line with quality directives.
- Work closely with the Senior QA Manager to develop and implement Training Plans.
- Compile Periodic Quality Reviews, providing valuable insights.
- Support the preparation, review, and processing of change controls.
- Organize change control meetings, gathering necessary information and data.
- Document the reasoning behind changes, outlining necessary steps for implementation.
- Drive the timely execution and closure of change controls, maintaining compliance with quality standards.
- Manage SOPs and training within the eDMS and eLMS systems.
- Assist in the rollout and allocation of training according to Role Plans and employee profiles.
- Ensure QMS compliance with SOPs and TrackWise system management (Deviations, CAPAs, Product Quality Complaints).
- Initiate internal deviations, allocate tasks, and guarantee timely resolution.
- Request local Periodic Quality Reviews from Contract Manufacturing Organizations and assist in compiling reports.
- Meet deadlines for completing assigned Company training.
- Forward received Product Quality Complaints, Adverse Events, and Medical Enquiries to relevant staff members.
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