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 communication

Governance & internal organization- Support 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 Metrics- Collect 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.

Training- Support 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 manner

Commitment Tracking- Manage 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 dates

Change Controls- Support 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 Audit- Lead the preparation and coordination of GMP/GDP related inspections of PCO Pfizer internal/MSQA audits- Work with SCMOQ Market lead and local functions to prepare an appropriate action plan to address the inspection/audit observation- Site Internal Audit (SIA) process management:
Setting the SIA plan according to local needs and subsystems prioritization tool

Ensure 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 Management- Perform, 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 Handling

Reporting complaints if any to AFME-HUB team withing the defined timeline.

Quality oversight on Local Relabeling operations- Ensure 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 Action- Attend, 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, communica