الوصف الوظيفي
This is a contract role under ManpowerGroup
Purpose/Objective of the job
The Quality Responsible Person complies with the GDP regulation for the Client’s Middle East markets.
This role is responsible for ensuring that a quality management system is implemented and maintained, for the distribution activities of products in all middle east markets, aligned both to market regulations as well as global quality framework.
Expected area of competence:
• Ensures the implementation and maintenance of quality management system, including the documentation and required records.
• Deals with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
• Impacts and influences the organization by escalating quality issues and decisions which impact the business.
• Ensures compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation.
• Ensures continuous improvement activities for more effective Quality systems across the organization.
• Active participation to company business growth objectives for quality alignment.
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
o Policy/Directives/SOPs impact assessment and implementation
o GDP and Local regulations impact assessment and implementation
? 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 customer 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 Market
? Implements adequate action plans for metrics achievement when necessary
2. Ensures implementation of following Quality Operations:
? Dubai HUB quality oversight, including approval of products to the markets as well as ensure export compliant to UAE 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
? Customers oversight: periodic customer verification compliance
? Product Quality status and batch release or approval to the market
? Local release process
? Handles compliance/quality issues with the impacted market team
? Attends the market action fact finding meetings when required and defines the adequate action plans within market
? 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 BMS 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 requirements are implemented in the Local Distribution Centre for:
? Warehousing facilities (HUB)
? 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 Wholesale Distributor License with Regulatory agency
? Import certificates, when requested
? Support the Global Quality Audits in the market
? Preparation of HA inspection in local entity and leading HA inspection
? Anticipate the new directives (Regulatory surveillance) and proactively drive change
المهارات
Education:
Must possess a pharmaceutical degree and certifications required by the local UAE regulation
Experience and Competences:
• 3-5 years of progressive managerial 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.
• Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
• Good verbal, written and presentation skills in English and Arabic; the ability to deal effectively with all levels of management.
• Innovative, creative and utilize available resources.
• Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems
• Team oriented worker with excellent interpersonal skills.
• 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.
• Demonstrated ability to influence, collaborate and communicate directly and to lead cross functional and cross regional teams.
• 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.
تفاصيل الوظيفة
منطقة الوظيفة دبي, الإمارات العربية المتحدة
قطاع الشركة وكالات التوظيف/التوظيف
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي مراقبة الجودة
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
المرشح المفضل
المستوى المهني متوسط الخبرة
*** تقدم على الرابط التالي : Apply on the following link ***
https://www.bayt.com/ar/uae/jobs/quality-compliance-3937091/
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