Quality Assurance Specialist Ksa and Gulf Countries

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United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**1 Year fixed term contract as a maternity leave replacement.**:
Reporting to the Head of Quality assurance, the purpose of the Quality Specialist role is to support the Head of Quality Assurance in the performance of Quality and Compliance tasks for Saudi Arabia and Gulf Countries Regions with regards to GMP and GDP requirements (including Medical Device guidelines) in alignment with the strategy defined with the business and global quality functions.

Support the Head of Quality Assurance with the implementation of the defined Global Healthcare Operations strategy and ensure the implementation and monitoring of the Quality Management System and their continuous improvement.

Tasks will include the management of product release, documentation, metrics / trend reports for deviations. In addition, this role will provide assistance with complaint management activities e.g. reporting, trend analysis etc.

Another key area of this role is the maintenance and creation of Standard Operating Procedures and Work Instructions, aligned with Healthcare Quality requirements; ensuring documents are available the electronic documentation system.

**Key Responsibilities**
- Manage the Complaints Process including the investigation process. Maintenance of all appropriate documentation, recording and investigation of customer complaints via the complaint database TrackWise; provision of information to complainants as required (complaint responses)
- Adherence to the Change Control and Deviation procedures including management of electronic system, TrackWise.
- Responsible for the compilation, tracking and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.
- Assist with the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensure procedures are available in the electronic Document Management system.
- Product Release: responsible for release of shipments including documentation review of shipping documents, product certificates and temperature loggers and compliance to local regulations.
- Participate in the Right First Time objective as part of product release activities and work with stakeholders to share the information and improve local processes as necessary
- prepare training presentations as needed e.g. for relevant GxP SOP’s & WI’s.
- Audit planning and execution including the tracking of CAPA plans till closure.
- Responsible for Risk Assessment and Management process.
- To recognize a reportable Adverse Event (AE) or Safety Information and ensure the information is forwarded to the Local Patient Safety Person (LPS) within the required timeframe.
- Assist with the Adverse Event / Product Complaint reconciliation process.
- Ensure regular update of the training matrix.
- Perform other activities and duties that may be assigned by the Head of Quality.
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Distribution activities that include**:

- Provide support to Cultivate a strong relationship with customers 3PL Providers, to ensure appropriate quality oversight.
- Interact, create and update quality agreements and SOPs with customers.
- Participate in the implementation of periodic quality reviews with key customers & third-Party Logistics based on relevant KPIs.
- Maintain quarantine status for products which has been proven to have hidden defects or suspicion of falsification.
- Perform mock recall as per company and regulatory guidelines.
- Establish and maintain Intracompany Quality Technical Agreements.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion