Job Description

Job title: Quality Specialist * Hiring Manager: Head of Quality MYBR * Location: Malaysia * Job type: Permanent About the job You will be part of the Quality team to ensure Quality operations and processes provide maximum value to the Busi Job title : Quality Specialist Hiring Manager: Head of Quality MYBR Location: Malaysia Job type: Permanent About the job You will be part of the Quality team to ensure Quality operations and processes provide maximum value to the Business Operations across assigned markets, whilst meeting applicable local national GxP & regulatory requirements as well as Sanofi standards & business expectation and continuity. You will ensure an efficient, effective and proactive Quality Product, System and performance delivery and handle country quality operation input into plans for product commercialization & rationalization. In this role, you will support the country quality operations for Malaysia, Brunei and Singapore and act as back- up to quality operations for Partner Markets countries, where you will co-ordinate and handle quality management processes and activities as per the quality agreement in these markets. Main responsibilities: Product Quality and related Quality Systems Handle product quality and related Quality systems according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions. Coordinate and handling product technical complaints received from the market according to Sanofi processes, standards, and appropriate tools in force, in connection with the concerned Global Quality functions. Manage product- related quality events such as product recalls and escalate quality events as necessary according to defined processes and standards. Coordinate in product recall management of EWD according to quality agreement in accordance with local regulation. Coordinate and communicate on Quality matters to the appropriate functions at country level and EWD according to the defined responsibilities vis vis Regulatory Authorities Perform local batch release and, vaccines batch release certification from Health Authority (HA). Monitor local GMP/ GDP activities (e.g., repackaging, storage, distribution, etc.) are performed in accordance with applicable GMP and GDP regulations. Management of Country Quality System Coordinate with Country Quality system for GxP and health-regulated activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory requirements. Coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to Quality, including the support to business and digital initiatives Maintain the Country Quality documentation management system, ensuring all process for management of GxP documents and records is in place in all GxP and health-regulated areas, considering data integrity principles Participate and co-ordinate Country Quality audits and GxP regulatory inspections Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings that require improvement to the appropriate global functions. Remain up to date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans. Perform training sessions and maintain personal qualification to be qualified in role and responsibility. Prepare and provide input to the country Quality Review and organize presentation to Country Senior Management. Deviation and Corrective- Preventive Actions (CAPA) Management and change control management Prepare and maintain valid and signed quality agreements with appropriate Sanofi manufacturing and distribution sites or/ and external organizations. Provide quality oversight of locally managed GxP subcontractors Back up for Quality Risk Management Maintain administrative records such as training log, job description as per GxP requirements Maintenance of local inventory of GxP Computerized Systems (CS), validated by relevant internal functions. Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating Quality Oversight of External Wholesale Distributor (EWD) in Partner Markets. Prepare and maintain of Quality and Technical Agreements in the business contract with EWD. Quality oversight and ensure process is in adherence to quality governance model. Conduct the relevant reconciliations between GxP functions and EWD. Maintain Quality Agreements with the Manufacturing sites and/or foreign MAH entities, where required. Back up to Quality Head/ Manager Act as back up to CQH for MYBR and Quality Management Ops MYBRSG, in critical quality matters Quality Alerts, recall, regulatory matters and to ensure business continuity About you Experience : Minimum 5 years of experience in Quality Assurance, Quality Management System in relevant industry. Technical skills : Familiar with GxP requirements, health regulations and Quality Management System Education : Degree in Pharmaceutical Sciences or similar disciplines. Languages : Proficient in written and spoken English Sanofi Behaviors and Skills This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, People Leadership (if applicable), Relationship and Influence. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our and check out our Diversity Equity and Inclusion actions at ! At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.