Key Responsibilities and Major Duties
1. Ensure that a Quality Management System is implemented and maintained in the local affiliate, including:
- Acts as the local Qualified Person responsible for GDP in accordance with market regulatory requirements
- Maintains Quality System Documentation: procedures and records
- Meeting the requirements of the defined Quality Unit activities
- Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
- Develops and maintain locally the Quality Manual
- Ensure that relevant distributor complaints are dealt with effectively
- Performs periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures
- Ensures implementation of Deviation and CAPA management
- Ensures implementation of the Change Control management
- Leads the Quality Management Review/Quality Council of the markets
- Implements adequate action plans for metrics achievement when necessary
2. Ensures implementation of following Quality Operations:
- Warehouse quality oversight, including approval of products to the markets as well as ensure export compliant to markets’ quality relevant regulations
- Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
- Distributor oversight: periodic distributor verification compliance
- Product Quality status and batch release or approval to the markets
- Local release process
- Handles compliance/quality issues with the impacted market team
- Ensures On Hold products request are observed
- Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls
- Decides on the final disposition of rejected, recalled or falsified products
- Approval of the returns to saleable stock, according to internal requirements
- Support Supply Chain to avoid Back Orders
- Provide quality input on shortage situations and oversight reporting to Health Authority
- Medical samples Quality distribution oversight
- Supports of sampling requested by HA(product, procedures, reference substances)
- Keeps appropriate records of any delegated duties
3. Facilitate that internal requirements are implemented in the Local Distribution Centre for:
- Warehousing facilities
- Secondary packaging facilities
- Transportation processes
4. Quality Risk Management
- Coordination and preparation of Quality Risk Management
- Participate in the periodic Business Review with the local Distribution Centre
5. Inspections and Regulatory Surveillance
- Maintenance of the License with Regulatory agency
- Import certificates, when requested
- Support the Global Quality Audits in the markets
- Preparation of HA inspection in local entity and leading HA inspection
- Anticipate the new directives (Regulatory surveillance) and proactively drive change
We are looking for someone with:
- Pharmaceutical degree and certifications required by the local UAE regulation (MOH licence valid in UAE is a must)
- 5-7 years of experience within the quality control function of the pharmaceutical health care industry and regulatory agencies
- Extensive knowledge and experience in quality system development , pharmaceutical health care operations, quality control, distribution and International regulations are essential.
- Proficient in GMPs, GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution
- Strong negotiating skills for interface with Health Authorities and market business functions
- Ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives.
- Excellent verbal, written and presentation skills in English and Arabic ; the ability to deal effectively with all levels of management. French language is an additional asset
- Demonstrate ability to switch priorities and manage more than one project at the time. Ability to plan and conduct projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
If you think you meet the expectations and are interested in joining BMS, please submit your CV in English.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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