MENA Region Quality Officer
2 days ago
Oximio is a leading organization in the field of quality assurance and compliance. We are committed to delivering high-quality services and products that meet the highest standards of excellence.
Job Summary:
We are seeking a highly skilled Global Quality Compliance Specialist to join our team. The successful candidate will be responsible for implementing quality procedures, standards, and specifications across all activities, ensuring compliance and taking corrective actions to minimize future occurrences.
Key Responsibilities:
- Implement global QA strategy locally, outlining goals for activities such as building effective QA procedures, audit standards, and ensuring consistent application, with appropriate corrective actions to minimize future occurrences.
- Develop and maintain local documentation, including P, SOP, WI, SF, and other documents that provide guidance and clarity on procedures concerning clinical trials logistics.
- Ensure all operations are performed according to applicable standard procedures and working instructions at the appropriate location.
- Drive improvement of effective Quality systems and procedures locally.
- Participate in review and approval of local and global SOP, WI, SF, and other documents that have an influence on the Oximio Quality system, aligned to the Oximio goals and values.
- Control the update of local SOP, WI, SF in a timely manner.
- Communicate new document issues/documents updates to Company personnel.
- Conduct training on QMS procedures for new employees and GxP training.
- Lead clients' external audits, providing documentation required during external audits and assessments, responding to observations occurred during external audits.
- Implement and control compliance with ISO 9001 and GxP requirements.
- Implement and control compliance with local and global legislation requirements.
- Conduct audits of suppliers (if necessary).
- Evaluate and approve suppliers ensuring they are aligned to established Quality standards.
- Prepare for ISO 9001 certification and lead further periodic inspections (if necessary).
- Participate in suppliers' audits (if necessary), control of suppliers' audits conducting and Supplier evaluation.
- Maintain regular review and effectiveness estimation of Quality system locally.
- Participate in Management Review process, preparing reports on the functioning of QMS processes.
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