Supply Chain Market Operation Officer

Maintain compliance to the local Board of Health (BOH) regulations Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met. Supports the Responsible Person and/or Qualified Person activities for all Pfizer Product Quality Compliance issues in the market as well as Health Authority Notification and documentation of any notification and any significant verbal communicationGovernance & internal organizationSupport timely implementation of all applicable Product Quality SOPs (issued by SCMOQ) within the PCO. Ensure that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs. Assess new quality system and local regulatory requirements to enhances and align local systems and processes when required. Conduct and document periodic assessments to determine if a revision, retirement, administrative change or no change is required for the Product Quality SOPs (issued by SCMOQ) within the PCO. Quality MetricsCollect data and report quality metrics for PCO operations to allow quality performance assessment. Together with the SCMOQ market lead, assess quality performance to identify trends and improvement opportunities. Participate in the PCO quality management reviews and follows-up for the recommended actions, when required. TrainingSupport the implementation of all elements of SCMOQ Training systems in the PCO, including implementation and refresher training on GDP/GMP to applicable PCO colleagues. Ensure that all assigned Pfizer trainings (through Pfizer LMS, Learning management system) are completed in a timely mannerCommitment TrackingManage commitments resulting from deviation management, change control, local regulatory authorities’ inspections, and internal audits. Use and maintain tracking tools to track any GxP commitments raised by SCMOQ or under SCMOQ oversight. For any commitment opened, ensure that due dates are based on risk, complexity and urgency, and that the timeframes given are realistic, to meet the stated requirements. Completion of all commitment tracking actions as per assigned due datesChange ControlsSupport the initiation and/or manage any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO. Participate in the change’s committee meeting as appropriate and ensure the required approvals are obtained. Ensures change action completion as per the agreed timelines. Inspection and Internal AuditLead the preparation and coordination of GMP/GDP related inspections of PCO Pfizer internal/MSQA auditsWork with SCMOQ Market lead and local functions to prepare an appropriate action plan to address the inspection/audit observationSite Internal Audit (SIA) process management:Setting the SIA plan according to local needs and subsystems prioritization toolEnsure the timely implementation of the SIA plan as per the assigned tasks as auditee and / or auditor.Product Quality Assurance & Operations Notification to Management (NTM)Notifies SCMOQ Sr Manager/TL and SCMOQ Regional Lead of significant product quality and compliance issues. Ensure notification is done within the appropriate timeline and process. Provide AQRT Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the PCO as applicable Ensure the local implementation of actions identified during AQRT meetings e.g. recalls, communication with Regulatory Agency, local CAPAs and provides feedback on progress Deviation and CAPA ManagementPerform, investigation of product quality incidents that occur within the responsibility of Pfizer Country Office in cooperation with the relevant internal/external functions. Track the preventive and corrective actions until completion within the set due dates. Product Complaint HandlingReporting complaints if any to AFME-HUB team withing the defined timeline.Quality oversight on Local Relabeling operationsEnsure that relabeling sites have been trained and approved before performing any relabeling activity. When required, ensure that the relevant Regulatory approval for the relabeling activity has been obtained by the regulatory team. Complete the required documentation and obtain the necessary approvals from Pfizer relevant functions. Oversee the process of relabeling and review operation related documents. Ensure SCMOQs release (as applicable) of the relabeled product according to Pfizer and local requirements Market ActionAttend, as needed (as back-up for example), Area Quality Review Teams (AQRT) meetings, as PCO representative, to provide the local perspective on the issue at hand. Support to provide the local perspective on the issue and draft the AQRT Executive Summary for issues originating under the responsibility of the PCO. Support the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actionsQuality agreementsDevelop, negotiate and maintain up to date quality agreements with all affiliates, GMP/GDP distributors involved in repackaging, storage and distribution activitiesQuality risk managementParticipate as risk leader or in the risk management committee for any opened risk with PCOManage the opened risk and tracking the required approvalUpdated risk tracker and archiving the risk assessment report as requiredQualifications/ SkillsYears of experience: 0-3 years in the Pharmaceutical or related regulated industryTechnical skills:Has an appropriate education in science or quality topics; Bachelor's degree, Pharmacist, Engineer. Has basic knowledge of the Quality principles, concepts of Quality and basic technical skillsHas basic knowledge about Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.)Able to Participate effectively in cross-functional teamAnalytical skillsExcellent level in English Soft Skills/ Management & Leadership SkillsSelf-motivated, Business acumenActs AssertivelyGrows SelfAccountableChange AgileSelf-AwarenessPlanning & Organizing skillsAble to make decisions within guidelines and policiesSuccess criteriaTo use new ideas and knowledge with increasing frequency, begins to explore and apply ingenuity to experimentation. Able to work in ambiguous situations as part of a Work TeamApplies technical skills to achieve assigned tasksHas effective communication, writing and negotiation skillsAble to align with global strategiesEfficiently represents Quality Compliance positionsPfizer 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