SCMOQ Officer

1-Maintenance of compliance with local market BOH regulationsSupports the market compliance status by ensuring product quality activities and temperature related customer enquiries conducted in accordance with local market regulations and Hub operating procedures in place.2-Product Quality Assurance & Operations1 - Product Complaint HandlingManage the intake and triage of complaints from the markets under PCO responsibility, classify the product complaint, and forwards them to the appropriate investigating PGS/Contractor manufacturing site via the global complaints management system (QTS-CITI). Develops and issues responses to complainants in a timely mannerTracks complaint responses. Notifies the Management when needed. 2 - Local Product Disposition & Temperature excursionReview all documents and records relevant to the imported products and perform the necessary activities to provide a disposition decision for the products for the market sale in compliance with local regulatory requirements and Pfizer procedures. Communicate the disposition decision to internal and external stakeholders. Document any temperature excursion and coordinate with manufacturing site for assessment and via the global Quality Tracking System (QTS). 3 - Deviation Management:Performs, if needed, investigation of product quality incidents that occur within the SCMOQ AFME Hub processes in cooperation with the relevant internal/external functions. Tracks the preventive and corrective actions until completion within the agreed time frame. 4 - Notification to Management:Informs SCMOQ Manager / SCMOQ Senior Manager of any significant deviations related to local product quality complaints management or temperature related customer enquiries, that could lead to an NTM. Ensures notification is performed within the appropriate timeline and process. 5- Product Quality Review (PQR) Handling:Ensures product listings are completed by the Markets in scope and provided to AFME HUB within required timelines annually. Ensures PGS sites are uploading their PQR planning schedules and APRR (Annual Product Review Reports) on Market Product Quality Review SharePoint within required timelines annually. Ensures External Supply Quality sites are completing their QTS listings within the required timelines annually. Maintains the process and document the completion of APRR through the global quality tracking system “gQTS” Commitment Tracking Module. 3-Governance & Internal Organization1- Quality Metrics:Collects data and quality metrics to allow quality performance assessment. 2-Training:Support the implementation of all elements of SCMOQ Training systems in AfME HUB. Ensures that all assigned training modules are completed in a timely manner. 3- Commitment Tracking:Uses tracking tools to track any GxP commitments related to SCMOQ AFME Hub processes. For any commitment opened, ensures that due dates are based on risk, complexity, and urgency, and that the timeframes given are realistic, to meet the stated requirements. 4- Change Controls:Supports planned, permanent and temporary changes of GDP/GMP related activities and systems within the SCMOQ AFME Hub. Ensures change control actions completion as per agreed timelines. 5- Inspection and Internal Audit:Participates as required in external and internal Audits as well in self-inspections to provide input on SCMOQ AFME Hub activities. Contributes when required to the development of CAPA plans. Internal self-inspection process management: Support / Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor. 6- Quality agreements:Review, negotiate, and maintain up to date Quality Agreements according to the SCMOQ Manager/ Sr SCMOQ Manager instructions. Work Location Assignment: On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control