Supply Chain Quality Officer

Maintenance of the compliance to the local BOH regulations
- Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.
- Support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market.
- Support Health Authority notifications and Documentation of any notification and any significant/verbal communication in scope of JD

Governance & internal organization
- Supports timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO for the following systems

Quality Metrics
- Support Collection of data related to quality metrics of quality systems under responsibility to allow quality performance assessment.
- Together with the SCQ Market lead, assess quality performance to identify trends and improvement opportunities.
- Participates in the PCO quality management reviews and follows-up for the recommended actions, when required.

Change Controls
- Initiate any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.
- Participates in the changes committee as appropriate and ensures the required approvals.
- Ensures change actions completion as per the agreed timelines.
- Reviews change control and signs change control form

Handling of Global and local SOPs:

- Responsible for follow up and assessing impact of newly updated global SOPs
- Responsible for review, update and maintenance of local SOPs

Commitment Tracking
- Tracking any GxP commitments raised by SCQ or under SCQ oversight Including Egypt and Sudan market under scope of responsibility.

Notification to Management
- Informs SCQ Market lead of any significant deviations and complaints, that could lead into a NTM and Ensure notification is done within the appropriate timeline and process.

Quarantine Alert Notice (QAN)
- Responsible for creation of QAN report for products / lots impacted with any quality issues
- Change the status of the impacted products / lots by QAN on PBG SAP system either Hold or release after resolving the quality issue.
- Forward the QAN report to the qualified Logistics service provider to ensure changing the products /lots status at their side to the desired status either Hold or release

Product Complaint Handling
- Reporting of any product quality complaint to AfME Hub in timely manner

Management of Label Text errors:

- Maintain the process of Label text error and ensure compliance to GSOPs
- Ensure compliance to reporting timelines and appropriate reporting level

Deviation Management
- Ensure Compliance of PCO to Pfizer deviation management Procedure
- Perform, if needed, investigation of product quality incidents that occur within the responsibility of Pfizer country office in cooperation with the relevant internal/external functions.

Local Product Disposition & Temperature excursion
- Participate in visit with MOH inspector for release document to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Pfizer procedures.

Management of reference standards:

- Support maintaining stocks of reference standards needed for analysis of products
- Support Periodic review of stocks to ensure they are matching with Products analysis needs

Local Repackaging/Relabeling operations
- Ensures that contractors have been assessed and approved before performing any relabeling/repackaging activity.

Returns
- Assessment of the returned goods and provide a disposition decision

Management of Quality Agreement:

- Responsible for creation and maintenance of Quality agreements for PCO Egypt vendors and service providers.

Management of Distributers and Contractors
- Support quality operations at contractors or provide feedback to the appropriate functions
- support and participate in MSQA audits
- Support with contractors/LSPs on action plans to address observations noted during the audits or visits

Market Action
- Attend, as needed, Area Quality Review Teams (AQRT) meetings, as PCO representative, to provide the local perspective on the issue at hand

Inspection readiness / Auditing:

- Responsible person to keepan acceptable inspection readiness state for Egypt PCO for both Pfizer internal and external / Regulatory quality audits
- Support in CAPA developmentfor both Pfizerinternal and external / Regulatory quality audits.
- Participate in quality audit for local distributers including audit preparation, execution, and reporting.
- Agree on CAPA plans with the audited distributers

Drug shortage reporting:

- Reporting Out of stock situations to Drug shortage department at BOH
- Responds to routine notifications inquired by drug shortage

Quality risk management:

- Ensure Compliance of quality Risk management process to Pfizer standards
- Participate as Risk leader or in the risk management committee for any opened risk

LSP / contractor management & oversight
- Participates as needed in contactors visits/ audits.