Location:
Petaling Jaya, MY, MY
Global Business Unit: HEC
Job Function: Regulatory Services
Requisition Number: 219327
Description:
Job Summary
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Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations
General Responsibilities
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Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
Supervise the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
Design quality management systems, include data management, quality criteria/checklists, supporting tools and techniques
Conduct investigations of non-conforming regulatory affairs activities, including identifying underlying causes, and suggesting corrective actions
Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
Identify training needs - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - and organize training interventions to meet quality standards
Coordinate quality development activities focusing on regulatory compliance such as audits, quality management reviews, and trainings
Provide technical assistance to internal stakeholders on regulatory affairs related issues, and trouble shooting when necessary
Liaise with internal and external stakeholders (i.e. government bodies) on regulatory affairs related queries, laws and regulations
Functional Skills and Knowledge
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Demonstrate knowledge in quality assurance tools, concepts and methodologies
Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
Demonstrate basic understanding of the Global Harmonized System (GHS)
Demonstrate good working knowledge, comprehension and applications of local regulations
Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
Demonstrate fluency in local language and ideally in English, both written and spoken
Education
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Diploma/certification of Science, Chemistry, Pharma or related disciplines