Job description / Role
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
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
Facilitate that internal requirements are implemented in the Local Distribution Centre for:
• Warehousing facilities
• Secondary packaging facilities
• Transportation processes
Quality Risk Management:
• Coordination and preparation of Quality Risk Management
• Participate in the periodic Business Review with the local Distribution Centre
Inspections and regulatory surveillance:
• Maintenance of the License with Regulatory agency
• Import certificates, when requested
• Support the Global Quality Audits in the markets
• 5-7 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, and 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 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.
About the Company
NTS Group is a leading specialist recruitment firm and experts at recruiting skilled, qualified and professional people in the Middle East.
Our promise is simple. To provide our clients and candidates an expert, professional and bespoke service whilst maintaining the highest levels of integrity and honesty.
NTS Group specialise within contingency, retained and search based recruitment campaigns across the following sectors;
Finance & Accountancy Professional Office Support Sales & Marketing Operations
To our clients, we understand people are your biggest asset and the future of your business. This is why we focus on understanding not only your technical requirements, but your culture, values and vision in order to find the right people for your business first time.
To our candidates, we believe in honesty, integrity and supporting you throughout the entire process. We listen to what you want and proactively go to market to assist you in finding your dream job.
Get personalised updates on latest vacancies
Quality Supervisor/Quality Manager - Infrastructure
|East Timor||28 Nov|