RAQA Senior Specialist/ Assist. Manager (OTC/ Pharma)

Key responsibilities

• Assist in product registration and renewals for assigned products in Hong Kong, the Macau, Mainland and other countries in a timely and accurate manner
• Perform QA related activities including quality management system (QMS), audit, regulatory affairs and product enquiry/complaint
• Arrange and coordinate the applications of different certificates, submit license renewal/change or other local registration to achieve the company goal.
• Assist to review the packaging and marketing materials for assigned products to ensure the compliance to laws and regulations; Overlook affiliate redressing activities (e.g. overlabeling, redressing) to ensure compliance with requirements and minimize risks.
• Manage and implement quality principles to ensure effective compliance of the quality system with the company policies, processes and procedures and all applicable regulations and industry standards, including establishment and maintenance of local procedures, work instructions, records and all applicable quality system documents
• Coordinate and investigate quality events such as deviations, nonconformities, complaints, and corresponding action plans including decisions on personnel assignments to assure continuous improvement of product and quality systems
• Establish and carry out a quality self-inspection program
• Communicate with internal and external customers on all quality and compliance-related matters
• Maintain RAQA documentary database
• Handle ad hoc project as required