QA Manager, Quality, HongKong

Found in: beBee jobs HK - 3 weeks ago

Hong Kong, Central and Western District, Hong Kong SAR China Takeda Pharmaceutical Full time

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ACCOUNTABILITIES

Management of Quality System for Hong Kong and Macau:

Own&Implement and maintain local quality system applying to GxP activities related to storage, distribution and commercialization of all products under development or marketed by Takeda or through partnership agreements, in compliance with Takeda Quality reference standards.Enhance quality culture & promote Quality mindset into the LOC level, working principles and ways of operating.Ensure appropriate communication of key messages pertaining to quality across the local organization, highlighting their possible business impactLead and coordinate a network of professionals designated in HK involved in GxP and health-regulated activities and embark them to address all matters related to quality.Internal/External Quality Audits and GxP Regulatory InspectionsDeviation and CAPA ManagementOwn and Implement a process to manage deviations and CAPAs related to all GxP activities including those related to audits and inspection findings, across the country in a consistent manner, and train concerned affiliate associates accordinglyChange Control ManagementManage the changes that may impact GxP process or operations by leading multidisciplinary exchanges and actions plans when necessaryTrainingOrganize and manage information sharing, training sessions or programs related to processes owned by QA for concerned HK associates, according to Takeda standards and regulatory requirementsQuality Management ReviewConduct Quality council according to Global Takeda SOPQuality AgreementEnsure that valid and signed quality agreements (with the country as contract giver) are in place for all GxP activities under the responsibility of Quality within HK organizationProduct Release, Product Return, Product Recall and Redressing activities for all products to ensure the compliance of GMP, GDP standard, company's requirements and relevant Hong Kong regulatory requirementsQuality Oversight of locally managed GxP SuppliersQuality of ProductsProduct Complaints (PCs)Manage product complaints received by the country according to Takeda processes, standards and appropriate tools in force, in connection with the concerned Global Quality functionProduct related Quality EventsEscalate quality events as necessary occurring at the local level according to defined processes and standards and manage subsequent quality alerts (as appropriate)Provide support to the appropriate functions at local level and according to the defined responsibilities vis a vis regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events)Other relevant Quality tasks, where applicableLeadership An understanding of industry, scientific and regulatory trends and market conditions, to help deployment of QMS within Hongkong and MacauEffective communicatorAbility to lead effectively through directing change as well as driving change by influenceAbility to lead and engage in complex investigations and propose sound, scientific, and compliant resolutionsAbility to coach and mentor colleague to support his developmentQualifications & SkillsLevel of EducationBachelor degree or higher, with major in scientific, engineering, medical or equivalent discipline.Working Experience in Relevant FieldAt least 5 years working experience in pharmaceutical industryExperience in interacting with health authorities, industry associationsExperience in affiliate (commercial) quality managementFluent in Chinese and English speaking and writingProfessional Knowledge and SkillsDigital and analytical skillsCritical thinking and problem solvingStrong communication skills in engaging local and global stakeholders (quality, manufacturing, supply chain, business, network)Strategic enterprise thinking with innovation mindsetLeading and influencing in a matrix environmentFluent in Chinese and English, both written and spokenLocations Hong Kong Worker Type Employee Worker Sub-Type Regular Time Type Full time

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