Assistant Vice President Quality Assurance & Regulatory Affairs

Assistant Vice President Quality Assurance & Regulatory Affairs

Job Openings Assistant Vice President Quality Assurance & Regulatory Affairs About the job Assistant Vice President Quality Assurance & Regulatory Affairs

Assistant Vice President, Quality Assurance & Regulatory Affairs (Location: Sumatera Island, Indonesia) Company Highlights Candidate will join a leading health-care group that is an industry-leader in a fast-growing and dynamicsector. The Company is a wholly-owned subsidiary of a global multinational, with over USD Billions in sales. Position Highlights Responsible for the Quality Assurance and Regulatory Affairs operations in collaboration with theCompany's Strategic Business Objectives. The job will entail spending Monday Saturday (half day) at the Company's production facility in Sumatera Island,Indonesia. Job Responsibilities Determines the QMS requirements of the Company starting from the incoming. inspection to the finalrelease of the products as per the required standard and customer requirements. Reviews the manufacturing processes and establishes the required SOP and WI to strengthen the QMSsystem. Knowledge of validation and qualification of processes/ products is required. Assuring product quality requirements at every stage of the production and ensuring minimum rejectionand rework in the process. Work to find defects, understand the causes, and provide solutions to defects and future problems. Ensures that other employees are trained to understand product quality standards and safetyrequirements. Have a clear knowledge of social compliance standards and establish systems and procedures. Periodically conduct an internal audit for QMS and SMS to identify the gaps to strengthen the system. Handling customer complaints and product failures by root cause analysis and effective implementationof CAPA. Acts as a role model in driving the assimilation of MST Core Values and Business Code of Conduct. Ideal Candidate Bachelor/ Masters in Polymer Science, Chemistry or Chemical Engineering. Minimum 20 years of relevant experience in quality assurance in chemical or medical devises industries . Has the relevant knowledge of the relevant Quality Standards applicable to Industry.

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