Primary Objective Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and local regulations. Core Job Responsibilities Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company Supports Complaint Handling/ post market surveillance and follow up actions Assignment of QMS training to employees on quality related documents and policies Preparation of monthly KPI data Provide inputs for Management Review Meeting including updates on adequacy and effectiveness of Quality Management system. Manages the document control for QMS procedures and quality records Support and prepare affiliate for Internal & External Quality & Compliance Audits. Prepare and help to obtain and maintain the GDPMD Certification and/or applicable Quality related certification in the region. Support external, internal and supplier audit and the follow-up remediation plan. Support investigation, defining root-cause and implementation of Corrective Action and Preventive Actions in a timely manner. Execution of Product Stop Shipment, Field Safety Corrective Actions as per instructions from Regional or Divisional QA. Interacts on a periodic frequency with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education and other functions on all quality related matters. Manage the change control process to meet amendment to local regulatory compliance requirements. OTHER FUNCTIONS AND RESPONSIBILITIES: Perform various administrative functions as required. Any other activities as assigned time to time by Line Manage Education/Qualifications/Experience Minimum of Bachelor's degree in Science. Equivalent education/work experience will be considered. Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage. Knowledge of local Medical Device regulations Computer proficiency in Word, Excel and PowerPoint. Strong interpersonal skills, with the ability to build and maintain relationships. Effective time management - well organized, able to set and reset priorities Strong oral and written communication skills. Detail and deadline oriented. Conversant local language as well both written and spoken English. Ability to work and flourish in a fast-paced multi-tasked environment Demonstrates a highly positive attitude concerning risk, change and unexpected challenges. Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information. Good in English Communication Skills Experience Required Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
